Three-year efficacy and safety of omidenepag isopropyl in patients with normal tension glaucoma.

PURPOSE: To retrospectively evaluate the 3-year efficacy and safety of single-agent omidenepag isopropyl in patients with normal tension glaucoma (NTG). STUDY DESIGN: Retrospective. METHODS: One hundred patients (100 eyes) who had newly been administered omidenepag isopropyl were enrolled in this study. Intraocular pressure (IOP) was compared at baseline and 6, 9, 12, 18, 24, 30, and 36 months after administration. The mean deviation values at baseline and 12, 24, and 36 months measured using the Humphrey visual field test (30-2 Swedish Interactive Threshold Algorithm standard) were compared. Adverse reactions and dropouts were assessed. RESULTS: IOP significantly decreased from 15.5±2.7 mmHg at baseline to 13.8 ±2.3 mmHg after 6 months, 13.9± 2.3 mmHg after 12 months, 13.9±2.3 mmHg after 18 months, 13.8±2.1 mmHg after 24 months, 13.9±2.0 mmHg after 30 months, and 13.6±1.7 mmHg after 36 months (P < 0.0001). There was no significant difference in the mean deviation values at baseline (-3.66±3.49 dB), 12 months (-3.41±3.80 dB), 24 months (-3.13±3.81 dB), and 36 months (-3.06±3.30 dB). Adverse reactions occurred in 11 patients (11.0%), including conjunctival hyperemia in 6 patients. Fifty-two patients (52.0%) were excluded from the analysis because they discontinued treatment either due to IOP measurement by NCT or the use of additional drugs. CONCLUSION: After the administration of omidenepag isopropyl, IOP in patients with NTG decreased within 3 years, visual fields were maintained, and safety was satisfactory. Thus, omidenepag isopropyl can be used as the first-line treatment for patients with NTG.

Glaucoma progression due to refraining examination amid the pandemic of COVID-19.

PURPOSE: Some patients refrained from seeking an ophthalmologist due to the anxiety and morbidity associated with the coronavirus disease (COVID-19) pandemic. We investigated progressive visual field defects in patients with glaucoma who refrained from ophthalmological examinations. METHODS: This was a retrospective study. We analyzed data from 886 patients with glaucoma who visited Inouye Eye Hospital in June 2022 and were followed-up prior to January 2020. We examined the number of times patients canceled visits between January 2020 and May 2022 due to coronavirus concerns. We assessed the mean deviation (MD) values of the Humphrey Visual Field Assessment (HFA) program 30-2 SITA Standard values after visit interruptions for worsening beyond the MD values predicted by the MD slope. Factors influencing this difference were analyzed using logistic regression analysis. RESULTS: The study included 374 men and 512 women. The mean age was 68.7 ± 12.0 years. Visit interruptions occurred in 146 patients (16.5%), with 95 (65.1%) rescheduling once, 27 (18.5%) twice, and 24 (16.4%) three or more times. Among 90 patients who underwent HFA regularly, 50 (55.6%) experienced worse-than-expected MD values and 12 (13.3%) deteriorated by 2 dB or more. Longer interruptions and high intraocular pressure before interruption worsened the MD values by 2 dB or more. CONCLUSION: Patients with glaucoma with visit interruptions due to the pandemic should be monitored for the progression of visual field impairment.

Switching to Brimonidine/Ripasudil Fixed Combination from Brimonidine + Ripasudil.

Purpose: A fixed-combination eye drop has several advantages over combination therapy, however, the intraocular pressure (IOP)-lowering efficacy and safety of the newly available brimonidine + ripasudil fixed-combination (BRFC) eye drops after switching from brimonidine + ripasudil is yet to be established. Therefore, this study aimed to retrospectively investigate the 6-month safety, usability, and IOP-lowering efficacy of BRFC switched from brimonidine and ripasudil. Patients and Methods: Overall, 69 patients with primary open-angle glaucoma (69 eyes) receiving brimonidine + ripasudil were enrolled in this study. Brimonidine + ripasudil was discontinued, and treatment was switched to BRFC without a washout period. The IOP was compared before and at 3 and 6 months after switching to BRFC. The side effects, discontinued cases, and usability (a questionnaire survey) were also investigated. Results: The IOP was not significantly different after switching to BRFC (15.1 ± 3.3 mmHg at baseline, 15.9 ± 3.6 mmHg after 3 months, and 14.6 ± 3.3 mmHg after 6 months). Adverse reactions occurred in four patients (5.8%): allergic conjunctivitis, two patients; irritation, one patient; and blurred vision, one patient. Treatment was discontinued in five (7.2%) patients owing to allergic conjunctivitis, two patients; increased IOP, two patients; and blurred vision, one patient. In the questionnaire survey, 68 patients with eye pain, 67 with itching, 64 with conjunctival hyperemia, 64 with irritation, and 62 with blurred vision reported no change or improved conditions. Additionally, in response to the question regarding preferences for pre-treatment and fixed combinations, 14 participants (20.2%) favored pre-treatment, while 53 (76.8%) preferred fixed combinations. Conclusion: The IOP was maintained for 6 months, with satisfactory safety and comfort of use, with BRFC switched from brimonidine and ripasudil.

Randomized Multicenter Clinical Trial Comparing 0.1% Brimonidine/0.5% Timolol Versus 1% Dorzolamide/0.5% Timolol as Adjuncts to Prostaglandin Analogues: Aibeta Crossover Study.

INTRODUCTION: This multicenter, randomized, comparative, and investigator-masked crossover clinical trial sought to compare the efficacy and tolerability of fixed combinations of 0.1% brimonidine/0.5% timolol (BTFC) versus 1% dorzolamide/0.5% timolol (DTFC) as adjunctive therapies to prostaglandin analogues. METHODS: A total of 110 patients with open-angle glaucoma or ocular hypertension previously treated with prostaglandin analogue monotherapy were randomized to receive either BTFC or DTFC as adjunctive therapy for 8 weeks. These patients were then crossed over to the alternative treatment arm for another 8 weeks. The reduction in intraocular pressure (IOP) (primary outcome), occurrence of adverse events, ocular discomfort after instillation, and patient preference (secondary outcomes) were recorded through patient interviews. RESULTS: BTFC instillation for 8 weeks reduced IOP by 3.55 mmHg, demonstrating non-inferiority to DTFC instillation (3.60 mmHg; P < 0.0001, mixed-effects model). Although adverse events were rare with both combinations, patients reported greater discomfort with DTFC than with BTFC (P < 0.0001). More patients preferred BTFC (P < 0.0001) over DTFC, as BTFC caused minimal or no eye irritation. CONCLUSION: As BTFC offered better tolerability than DTFC with comparable reduction in IOP, we recommend it as an alternative for patients who experience ocular discomfort with DTFC-prostaglandin analogue combination therapy. TRIAL REGISTRATION NUMBER: jRCTs051190125.

Patients with glaucoma who require further reduction in intraocular pressure while undergoing monotherapy with prostaglandin analogue ophthalmic solution have been prescribed two enhanced treatment options: 0.1% brimonidine/0.5% timolol fixed combination ophthalmic solution (BTFC) and 1% dorzolamide/0.5% timolol fixed combination ophthalmic solution (DTFC). The Aibeta Crossover Study Group in Japan compared the efficacy and tolerability of fixed combinations of BTFC versus DTFC when an additional fixed combination ophthalmic solution was prescribed in patients with open-angle glaucoma or ocular hypertension who had been treated with prostaglandin analogue monotherapy. We recruited 110 patients previously treated with prostaglandin analogue monotherapy at 20 clinical centers in Japan, then randomly assigned them to two alternative treatment groups: the BTFC to DTFC group or the DTFC to BTFC group, as an adjunctive therapy to prostaglandin analogues for total of 16 weeks. We compared the reduction in intraocular pressure, occurrence of side effects, eye discomfort after instillation, and patient preference between BTFC versus DTFC instillations. The intraocular pressure reduction of BTFC instillation was comparable to that of DTFC instillation, showing non-inferiority to DTFC (3.55 mmHg vs. 3.60 mmHg; P < 0.0001, mixed-effects model). Both eye drops caused few side effects; however, patients felt greater eye discomfort with DTFC than with BTFC (P < 0.0001). Because of less eye irritation, more patients preferred BTFC (P < 0.0001) over DTFC. We can recommend using BTFC for patients who feel eye discomfort with DTFC­prostaglandin analogue combination therapy.

One-Year Efficacy and Safety of Omidenepag Isopropyl in Patients with Normal-Tension Glaucoma.

Purpose: To retrospectively evaluate the 1-year efficacy and safety of single-agent of omidenepag isopropyl in patients with normal-tension glaucoma (NTG). Methods: One hundred patients (100 eyes) newly administered omidenepag isopropyl were enrolled. Intraocular pressure (IOP) was compared at baseline and 3, 6, 9, and 12 months after administration. The mean deviation values at baseline and 12 months measured using the Humphrey visual field test (30-2 Swedish Interactive Threshold Algorithm standard) were compared. Adverse reactions and dropouts were observed. Results: IOP significantly decreased from 15.5 ± 2.7 mmHg at baseline to 13.3 ± 2.5 mmHg after 3 months, 13.7 ± 2.3 mmHg after 6 months, 13.9 ± 2.4 mmHg after 9 months, and 13.7 ± 2.3 mmHg after 12 months (P < 0.0001). There was no significant difference in the mean deviation values at baseline (-3.66 ± 3.49 dB) and after 12 months (-3.41 ± 3.80 dB). Adverse reactions occurred in 9 patients (9.0%): conjunctival hyperemia (n = 6), eye pain (n = 1), iritis (n = 1), and blepharitis (n = 1). Twenty-one patients (21.0%) discontinued administration because of changes in medication (n = 7), interruption of visits (n = 5), adverse reactions (n = 4), and others. Conclusions: After administering omidenepag isopropyl, the IOP in patients with NTG decreased within 1 year, visual fields were maintained, and safety was satisfactory. Omidenepag isopropyl can be used as the first-line medication for patients with NTG.

Periocular Adverse Reactions to Omidenepag Isopropyl.

PURPOSE: To investigate the periocular adverse reactions to omidenepag isopropyl (OMDI). DESIGN: Nonrandomized comparative clinical study. METHODS: We enrolled 100 patients (100 eyes) with primary open-angle glaucoma or ocular hypertension who received initial treatment with OMDI or tafluprost in only 1 eye for ≥6 months. Photographs of the eyelids were taken on the day of the participants' visit after ≥6 months of prescription. Subsequently, 3 ophthalmologists individually determined the occurrence of eyelid pigmentation, eyelash growth, and deepening of the upper eyelid sulcus (DUES). Additionally, a questionnaire on the subjective symptoms was administered. Multivariate analysis of baseline data was performed to investigate the factors involved in adverse reactions. RESULTS: The mean duration of drug administration was 10.2 ± 3.8 and 10.8 ± 4.1 months in the OMDI and tafluprost groups, respectively. The frequencies of eyelid pigmentation, eyelash growth, and DUES were 0.0%, 0.0%, and 2.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 4.0%, 32.0%, and 12.0%. The only significant difference was that the OMDI group showed fewer patients with eyelash growth than in the tafluprost group (P < .0001). In the questionnaire, the subjective symptoms of eyelid pigmentation, eyelash growth, and DUES were 8.0%, 2.0%, and 4.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 12.0%, 40.0%, and 4.0%, respectively. Multivariate analysis revealed a correlation between the type of drug administered and these adverse reactions (R = 0.38, P = .005). CONCLUSIONS: The frequencies of periocular adverse reactions to OMDI, ranging from 0% to 2.0%, were lower than those to tafluprost.

Changes in corneal endothelial cell shape after treatment with one drop of ROCK inhibitor.

PURPOSE: We performed an investigation of the temporal impact on corneal endothelial cell (CEC) shape after ophthalmic instillation of one drop of the ROCK inhibitor, ripasudil. METHODS: Subjects comprised 32 healthy adult volunteers, each of whom instilled ripasudil in the right eye. CEC shape [defined as CEC density (CECD), coefficient of variation (CV), and hexagonal cell rate (6A)], central corneal thickness (CCT), intraocular pressure (IOP), and conjunctival hyperemia were evaluated before instillation (baseline) and at 15 min, 1 h, 2 h, and 4-6 h after instillation by non-contact specular microscopy and slit-lamp microscopy. The incidence of pseudo gutta was also assessed. RESULTS: The CECD (cells/mm2) significantly decreased after instillation as follows: 2661 cells/mm2 at baseline, 2578 cells/mm2 at 15 min, 2527 cells/mm2 at 1 h, 2575 cells/mm2 at 2 h, and 2613 cells/mm2 at 4-6 h. After instillation, CV significantly increased and 6A significantly decreased. Pseudo gutta appeared in 18 subjects (56.3%) after instillation. There was no difference in CCT before and after instillation. IOP significantly decreased after instillation. The most severe conjunctival hyperemia was observed at 15 min after instillation, but had nearly disappeared within 2 h. CONCLUSIONS: Pseudo gutta appeared in more than half of the subjects, and the CEC shape changed upon instillation of one drop of ripasudil; however, it recovered at 4-6 h after instillation. Therefore, these changes would not greatly impact clinical treatment. Similar to the presence of conjunctival hyperemia, changes in CEC shape occur at early stages after instillation of ripasudil.

Short-term Efficacy and Safety of a Latanoprost/Carteolol Fixed Combination Switched From Concomitant Therapy to in Patients With Primary Open-angle Glaucoma or Ocular Hypertension.

PURPOSE: We prospectively investigated the efficacy and safety of switching from concomitant latanoprost and carteolol hydrochloride (CH) to a latanoprost/carteolol fixed combination (LCFC) in patients with primary open-angle glaucoma or ocular hypertension. PATIENTS AND METHODS: A total of 43 patients (43 eyes) who were using latanoprost (once daily in the evening) and CH (once daily in the morning) concomitantly were switched to LCFC (once daily in the morning) with no washout interval. The primary efficacy endpoint was change in intraocular pressure (IOP) between baseline (before switching) and 1 and 3 months after switching. Systemic blood pressure and pulse rate, corneal epithelial defects, and tear film break-up time (TBUT) were also compared before and 1 and 3 months after switching. A questionnaire was administered 1 month after switching to investigate ocular comfort and treatment preferences. Adverse reactions and dropouts were recorded. RESULTS: There was no significant difference in IOP after switching to LCFC (15.0±2.6, 15.1±2.4, and 15.0±2.4 mm Hg at baseline and at 1 and 3 months, respectively). There was a significant decrease in corneal epithelial defects and significant increase in TBUT, without significant changes in systemic blood pressure or pulse rate. Three patients (7.3%) preferred concomitant latanoprost and CH; 33 (80.5%) preferred the LCFC. One patient each (9.3%) discontinued treatment because of foreign body sensation, blepharitis, increased IOP, or loss to follow-up. CONCLUSIONS: Switching from concomitant latanoprost and CH to LCFC led to similar IOP control with good safety and patient acceptance, at least in the short term.

Switching from concomitant therapy to tafluprost/timolol fixed combination.

PURPOSE: To evaluate the efficacy and safety of tafluprost/timolol fixed combination (TTFC). STUDY DESIGN: A prospective clinical study. METHODS: Twenty-eight patients (28 eyes) with primary open-angle glaucoma, who had used tafluprost and timolol gel for at least 3 months with good adherence, were enrolled. Concomitant administration of tafluprost and timolol was switched to TTFC without a washout period. The intraocular pressure (IOP), blood pressure, pulse rate, and ocular signs were compared between before switching (baseline), and 4 and 8 weeks after switching. A questionnaire survey was also performed 4 weeks after switching to investigate ocular comfort and patient preferences. RESULTS: The IOP showed no significant change after switching to TTFC (14.8 ± 2.8, 14.6 ± 3.4, and 14.8 ± 3.7 mmHg at baseline, Week 4, and Week 8, respectively). The pulse rate and systolic blood pressure showed no changes, but diastolic blood pressure was significantly lower at Week 8. At baseline, fluorescein staining revealed corneal abnormalities in 3 patients, which resolved by Week 8 in 1 patient. Hyperemia was noted in 2 patients at baseline, and this also resolved by Week 8 in 1 patient. Three patients discontinued study treatment for the following reasons (1 patient each): blurred vision; ocular irritation, eyelid erythema, and asthenopia; and loss to follow-up from Week 8. The questionnaire survey revealed no significant differences between the 2 treatments, although more patients preferred TTFC. CONCLUSION: Among 28 patients enrolled, only 2 patients discontinued the study treatment due to adverse reactions. In patients whose adherence was considered relatively good to concomitant therapy, switching to TTFC achieved similar IOP control with good safety and a high level of patient acceptance.

Efficacy and safety of adding ripasudil to existing treatment regimens for reducing intraocular pressure.

PURPOSE: Ripasudil accelerates aqueous humour drainage along the trabecular meshwork-Schlemm's canal route and has been approved for clinical use in Japan. We retrospectively investigated the efficacy and safety of adding ripasudil to existing treatment regimens to reduce intraocular pressure (IOP) in patients with glaucoma. METHODS: A total of 119 eyes from 119 subjects (61 men, 58 women) with primary open-angle glaucoma or ocular hypertension who had ripasudil added to their treatment regimens between December 2014 and June 2015 were included. An average of 3.8 ± 1.0 anti-glaucoma medications was in use before adding ripasudil. Subjects were divided into four groups based on the number of medications included in the original treatment regimen: ≤2, 3, 4, or ≥5 medications. The IOP was compared before and after 1 and 3 months of treatment with ripasudil for all subjects and between groups. Patients for whom ripasudil use was discontinued within 3 months were also examined. RESULTS: The IOP was significantly lower in all patients after 1 month (17.5 ± 4.5 mmHg) and 3 months (16.8 ± 4.2 mmHg) of treatment than it was before (19.8 ± 5.3 mmHg, p < 0.0001). All groups were equivalent in the rate and magnitude of IOP change. Ripasudil administration was discontinued in five patients (4.2%) prior to the end of the study: three were lost to follow-up and two underwent glaucoma surgery. CONCLUSION: Adding ripasudil to existing glaucoma treatment regimens is effective and safe in reducing IOP, regardless of the number of medications in use.

Safety and efficacy of switching from dorzolamide 1.0%/timolol maleate 0.5% eye drops to brinzolamide 1.0%/timolol maleate 0.5% eye drops.

PURPOSE: To evaluate the safety and efficacy of switching from dorzolamide 1.0%/timolol maleate 0.5% fixed-combination (DTFC) eye drops to brinzolamide 1.0%/timolol maleate 0.5% fixed-combination (BTFC) eye drops in patients with primary open-angle glaucoma or ocular hypertension. METHODS: A total of 35 eyes of 35 patients with primary open-angle glaucoma or ocular hypertension using DTFC eye drops were included. Participants discontinued DTFC drops and immediately began using BTFC drops. All other eye drops currently being used were continued. Intraocular pressure (IOP) 1 and 3 months after switching medications was compared with baseline IOP. One month after switching medications, participant preference and adherence were evaluated. Adverse reactions were monitored at each study visit. RESULTS: The IOP was 17.9±2.6 mmHg at baseline and 18.3±4.1 mmHg and 17.8±3.4 mmHg 1 month and 3 months after switching medications, respectively (P=0.633). The frequency of missing a dose was not different before (6.1%) and after (6.1%) switching to BTFC. Significantly fewer participants reported stinging after switching to BTFC (15.2%) than while using DTFC (51.5%, P,0.01). Blurred vision was reported with the same frequency before (39.4%) and after (42.4%) switching to BTFC. A total of 33.3% and 27.3% of patients preferred DTFC and BTFC, respectively. Several patients withdrew from the study because of discomfort (n=2, 5.7%), discharge (n=1, 2.9%), dizziness (n=1, 2.9%), or increased IOP (n=2, 5.7%). CONCLUSION: Switching from DTFC to BTFC was well tolerated and did not result in IOP changes or a decreased patient adherence. When glaucoma patients complain of stinging with DTFC administration, switching to BTFC is an acceptable treatment option.

Effects of treatment with bimatoprost 0.03% for 3 years in patients with normal-tension glaucoma.

PURPOSE: To evaluate the effects of bimatoprost 0.03% single treatment for 3 years on intraocular pressure (IOP) and visual field performance. METHODS: We monitored the IOP of 62 patients with normal-tension glaucoma every 1-3 months. The Humphrey visual field test was performed every 6 months after treatment and the results obtained were compared to those before treatment. In addition, visual field performance was evaluated using trend and event analysis. RESULTS: The mean ± standard deviation (SD) of IOP after treatment with bimatoprost for 3 years (13.6±3.1 mmHg) was significantly lower than that before treatment (16.8±2.4 mmHg, P<0.0001). No change was observed in the mean deviation and pattern SD values of the Humphrey visual field before and 3 years after treatment. Worsening of visual field performance was observed in one patient (3.0%) by using trend analysis and in four patients (12.1%) by using event analysis. Treatment was discontinued in 17 patients (27.4%) because of adverse reactions. CONCLUSION: Bimatoprost 0.03% single treatment was effective in reducing the IOP at least during the 3 years of treatment, but visual field performance worsened by 3.0%-12.1% in patients with normal-tension glaucoma.

Deepening of the upper eyelid sulcus caused by 5 types of prostaglandin analogs.

PURPOSE: Upper eyelid sulcus deepening has recently been reported as an adverse effect of prostaglandin (PG) eye drop use. However, no data are available regarding the frequency of upper eyelid sulcus deepening caused by different types of PG eye drops. We used 5 types of PG eye drops in Japanese subjects and examined the frequency of appearance of upper eyelid sulcus deepening in these subjects. PATIENTS AND METHODS: The study included 250 patients (250 eyes) diagnosed with primary open-angle glaucoma or ocular hypertension. Five healthy patients were included as controls. One eye of each patient was treated with one of the following PG eye drops for >3 months: latanoprost, travoprost, tafluprost, bimatoprost, and isopropyl unoprostone. A single-lens reflex camera was used to photograph the open eyelids. Three ophthalmologists independently judged the appearance of the deepened upper eyelid sulcus in the photographs of the 250 patients and 5 controls by comparing the right and left eyes. A subjective self-reported symptom questionnaire was also administered. RESULTS: Upper eyelid sulcus deepening was objectively (photograph) and subjectively (questionnaire) noted in 24.0% and 12.0%, 50.0% and 24.0%, 18.0% and 10.0%, 60.0% and 40.0%, and 8.0% and 10.0% of the patients in the latanoprost, travoprost, tafluprost, bimatoprost, and unoprostone groups, respectively. It occurred more frequently (objectively and subjectively) in the bimatoprost group than in the latanoprost, the tafluprost, and the unoprostone groups (P<0.001). CONCLUSION: Upper eyelid sulcus deepening frequently occurred with bimatoprost usage, and this effect should be sufficiently elucidated before starting bimatoprost treatment.

Three-month evaluation of dorzolamide hydrochloride/timolol maleate fixed-combination eye drops versus the separate use of both drugs.

PURPOSE: To investigate the ocular hypotensive effect and safety of dorzolamide hydrochloride 1 %/timolol maleate 0.5 % fixed-combination eye drops. METHODS: The study cohort comprised 34 patients with either primary open-angle glaucoma or ocular hypertension who were being concomitantly treated with dorzolamide hydrochloride 1 % eye drops and timolol maleate 0.5 % eye drops. The dorzolamide hydrochloride 1 % and timolol maleate 0.5 % eye drops were replaced with dorzolamide hydrochloride 1 %/timolol maleate 0.5 % fixed-combination eye drops without any washout period. The intraocular pressure (IOP) was evaluated both before and 1 and 3 months after the treatment change. The patients were asked to complete a questionnaire on adherence to the treatment protocol 1 month after the change in treatment. RESULTS: The IOP was 15.5 ± 2.7 mmHg at the time of treatment change, 15.2 ± 2.7 mmHg at 1 month post-change, and 15.5 ± 2.9 mmHg at 3 months post-change, which is consistent with that before the treatment change (p = 0.286). Based on the completed questionnaire, following the treatment change, 50 % of patients felt a stinging sensation following administration of the eye drops and 11.8 % experienced blurred vision. In no case were the eye drops discontinued due to adverse reactions or insufficient IOP decrease. CONCLUSION: The replacement of concomitant treatment with dorzolamide hydrochloride 1 % and timolol maleate 0.5 % eye drops with dorzolamide hydrochloride 1 %/timolol maleate 0.5 % fixed-combination eye drops improved protocol adherence and preserved the IOP.

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension.

PURPOSE: To prospectively investigate adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. We also examined patient attitudes to adverse reactions via a questionnaire. METHODS: Fifty-two Japanese patients with glaucoma or ocular hypertension were enrolled. Iridial, eyelid, and eyelash photographs were taken before and at 6 months after bimatoprost treatment. Increase in eyelid pigmentation, iridial pigmentation, eyelash growth and bristle, and vellus hair of the lid was assessed from the photographs. Questionnaires completed by patients provided insight into their subjective judgment of adverse reactions. RESULTS: Increase in eyelash bristle (53.8%), iris pigmentation (50.0%), eyelash growth (46.2%), vellus hair of the lid (40.4%), and eyelid pigmentation (7.7%) was evident after bimatoprost treatment. The objective and subjective assessments were in agreement in terms of increase in eyelash bristle, eyelash growth, and increase in vellus hair of the lid. CONCLUSION: Most patients were conscious of these adverse reactions. Before administering bimatoprost, sufficient explanation of potential adverse reactions should be provided; after initiating treatment, careful observation is required.