Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth.

BACKGROUND: Ocularly applied bimatoprost 0.03% is associated with increased eyelash growth. OBJECTIVE: To assess the safety, efficacy, and subjective experience of using dermal application of bimatoprost 0.03% for the growth of natural eyelashes. METHODS: Prospective, open-label study of subjects who desired longer, thicker (fuller), and darker natural eyelashes. Bimatoprost was applied to the upper lid margin once daily for 12 weeks. Adverse events and intraocular pressure were assessed, and subjects completed health outcomes questionnaires. Eyelash growth and darkening were scored using photographs taken at weeks 1 and 12. RESULTS: All subjects were female (N=28). No serious or unexpected adverse events were reported. The mean change from baseline intraocular pressure was less than 1 mmHg at each time point, but was statistically significant at weeks 1 and 4 (p< or =.047). At week 12, all subjects had noticed significant growth or darkening. Post hoc analysis of photographs corroborated these reports (p<.001). CONCLUSION: Bimatoprost was found safe for eyelid application and was associated with enhanced eyelash growth. All subjects noticed favorable changes in the appearance of their eyelashes.

Fixed-combination brimonidine/timolol as adjunctive therapy to a prostaglandin analog: a 3-month, open-label, replacement study in glaucoma patients.

PURPOSE: To evaluate intraocular pressure (IOP) and ocular allergy after replacement of 1 of 2 adjunctive therapy regimens (fixed-combination dorzolamide/timolol or dorzolamide/timolol plus brimonidine) with fixed-combination brimonidine/timolol in glaucoma patients treated with ongoing prostaglandin analog (PGA) therapy. METHODS: This prospective, nonrandomized, open-label study involved patients on dorzolamide 2%/timolol 0.5% and a PGA who needed lower IOP and patients on brimonidine, dorzolamide 2%/timolol 0.5%, and a PGA who wanted to simplify their treatment regimens. After the baseline evaluation, patients were continued on the PGA and their other IOP-lowering medications were replaced with brimonidine 0.2%/timolol 0.5%. IOP was measured at baseline and months 1 and 3. RESULTS: In patients who replaced dorzolamide/timolol with brimonidine/timolol (n = 45), the mean (SD) IOP was 15.9 (1.4) mm Hg at baseline, 13.3 (0.9) mm Hg after 1 month (P < 0.001 vs. baseline), and 13.3 (1.0) mm Hg after 3 months (P < 0.001 vs. baseline). In patients who replaced both brimonidine and dorzolamide/timolol with brimonidine/timolol (n = 15), the mean (SD) IOP was 15.9 (5.2) mm Hg at baseline, 13.8 (1.8) mm Hg after 1 month (P = 0.053 vs. baseline), and 13.8 (1.4) mm Hg after 3 months (P = 0.079 vs. baseline). Allergy was reported in 5 patients previously treated with dorzolamide/timolol and 1 patient previously treated with brimonidine plus dorzolamide/timolol. CONCLUSIONS: For patients on multiple-drug therapy including a PGA, replacement of dorzolamide/timolol with brimonidine/timolol may help achieve a lower IOP, while replacement of brimonidine plus dorzolamide/timolol with brimonidine/timolol may help achieve as low an IOP with fewer medications.

A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients.

PURPOSE: To evaluate whether adding perioperative topical ketorolac tromethamine 0.4% improves cataract surgery outcomes relative to topical steroids alone in patients without known risk factors for cystoid macular edema (CME). DESIGN: Prospective, randomized, investigator-masked, multicenter clinical trial. METHODS: Patients scheduled to undergo phacoemulsification and with no recognized CME risks (diabetic retinopathy, retinal vascular disease, or macular abnormality) were randomized to receive either prednisolone acetate 1% 4 times daily (QID) alone (steroid group; n = 278) or prednisolone 1% QID plus ketorolac 0.4% QID (ketorolac/steroid group; n = 268) for approximately four weeks postoperatively. In the ketorolac/steroid group, patients also received topical ketorolac 0.4% QID for three days preoperatively. In both groups, patients received four doses of ketorolac 0.4% one hour before surgery. Patients with capsular disruption or vitreous loss intraoperatively were exited from the study. Outcome measures included CME incidence, retinal thickness as measured by optical coherence tomography (OCT), best-corrected visual acuity, and contrast sensitivity. RESULTS: No patients in the ketorolac/steroid group and five patients in the steroid group had clinically apparent CME (P = .032). Based on OCT, no ketorolac/steroid patient had definite or probable CME, compared with six steroid patients (2.4%; P = .018). In the ketorolac/steroid group, mean retinal thickening was less (3.9 microm vs 9.6 microm; P = .003), and fewer patients had retinal thickening of more than 10 microm as compared with the steroid group (26% vs 51%; P < .001). CONCLUSIONS: This study suggests that adding perioperative ketorolac to postoperative prednisolone significantly reduces the incidences of CME and macular thickening in cataract surgery patients already at low risk for this condition.

A multicentre evaluation of the effect of patient education on acceptance of hyperaemia associated with bimatoprost therapy for glaucoma or ocular hypertension.

INTRODUCTION: The aim of this study was to evaluate the incidence of hyperaemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperaemia. METHODS: This was a multicentre, open-label, evaluator-masked clinical trial of 106 patients. Prior to enrolling in the trial, patients were washed out from any ocular hypotensive medications and prescribed bimatoprost daily in the evening for 6 weeks. Patients were randomised to one of two groups: intervention and no intervention. Patients in the intervention group (n=63) were given a fact sheet explaining the importance of reducing intraocular pressure (IOP) and the efficacy of bimatoprost, while patients in the no intervention group (n=43) were instructed only to instil bimatoprost daily and were given no additional instructions. RESULTS: As graded by the masked investigators, conjunctival hyperaemia peaked 1 day after commencing bimatoprost, with a mean of 1.2 (0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe). By day 7, hyperaemia levels were approximately trace (0.79) and continued to decrease throughout the study. There were no significant differences between groups in mean conjunctival hyperaemia at any study visit (P> or =0.215). At every visit, patients in the intervention group were significantly more likely than patients in the no intervention group to report that lowering IOP was very important for preserving vision (P< or =0.001). At week 6, 98% of patients in the intervention group reported that IOP-lowering was very important for preserving vision, compared with 76% of patients who did not receive the intervention (P< or =0.001). Patients in the intervention group were more likely than patients in the no intervention group to be willing to continue to use bimatoprost, despite hyperaemia. This difference was statistically significant at day 1 (P=0.003). CONCLUSION: Patients were not bothered by the trace.mild hyperaemia associated with bimatoprost therapy. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.

Ocular hypotensive efficacy of brimonidine 0.15% as adjunctive therapy with latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension.

This study was undertaken to evaluate the ocular hypotensive efficacy of brimonidine Purite 0.15% (Alphagan P 0.15%; Allergan, Inc., Irvine, Calif) given as adjunctive therapy with latanoprost 0.005% (Xalatan; Pfizer Inc., New York, NY( to patients with open-angle glaucoma or ocular hypertension. In this multicenter, open-label, prospective evaluation, the intraocular pressure (IOP) of the 43 enrolled patients was > or =18 mm Hg after at least 6 wk of latanoprost monotherapy. The primary outcome measure was IOP at peak drug effect )10 AM, or approximately 2 h after the morning dose of brimonidine 0.15%(. IOP at trough drug effect (8 AM, or approximately 12 h after the evening dose of brimonidine) was also measured. Baseline IOP was 21.9 (+/-2.3) mm Hg. After 1 mo of treatment, additional mean IOP reductions from latanoprost-treated baseline values were 5.8 mm Hg (26%) at peak drug effect (P<.001) and 3.3 mm Hg (15%) at trough (P<.001). At the month 2 visit, additional mean IOP reductions from latanoprost-treated baseline values were 5.1 mm Hg (23%) at peak drug effect (P<.001) and 2.0 mm Hg (9%) at trough (P=.002). Brimonidine Purite 0.15% provided statistically significant additional reductions in IOP from latanoprost-treated baseline values. These findings suggest that brimonidine Purite 0.15% is an efficacious adjunctive therapy in patients given latanoprost who require additional lowering of IOP.

Comparing bimatoprost and travoprost in black Americans.

OBJECTIVE: To compare the intraocular pressure-lowering efficacy and safety of topical bimatoprost 0.03% with that of travoprost 0.004% for the treatment of black patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). RESEARCH DESIGN AND METHODS: Multicenter, prospective, randomized, investigator-masked trial of 94 black patients previously diagnosed with OAG or OHT. All patients completed washout of ocular hypotensive medications before study participation. Patients were assigned to either once-daily bimatoprost 0.03% or once-daily travoprost 0.004% for 3 months. MAIN OUTCOME MEASURES: The primary outcome measures were mean intraocular pressure (IOP), mean change from baseline IOP, and percentage of patients who reached a target IOP reduction. Secondary measures included ophthalmologic examination and adverse events. RESULTS: Both bimatoprost and travoprost significantly lowered IOP at all study visits (p < 0.001). Bimatoprost provided mean IOP reductions from baseline that ranged from 6.8 mmHg to 7.8 mmHg (27% to 31%). Travoprost provided mean IOP reductions from baseline that ranged from 6.2 mmHg to 6.9 mmHg (25% to 28%). By month 3, 85% of participants in the bimatoprost group had a mean IOP reduction of at least 20%, compared with 68% of those in the travoprost group. Furthermore, 31.9% of those in the bimatoprost group had a mean IOP reduction of more than 40% at month 3 compared with 20.9% of those in the travoprost group. There were no significant differences in biomicroscopy, ophthalmoscopy, or visual acuity. Ocular redness was the most commonly reported adverse event in both treatment groups. No serious adverse events were reported. CONCLUSIONS: Bimatoprost and travoprost each effectively lowered IOP in this population of black patients. More patients achieved clinically relevant IOP reductions with bimatoprost.

A 3-month clinical trial comparing the IOP-lowering efficacy of bimatoprost and latanoprost in patients with normal-tension glaucoma.

This multicenter, randomized, double-blind clinical trial was undertaken to compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with that of latanoprost 0.005% for the treatment of patients with normal-tension glaucoma. After washout of all ocular hypotensive medications, patients with normal-tension glaucoma (n=60) were randomly assigned to oncedaily bimatoprost 0.03% or latanoprost 0.005% for 3 mo. Diurnal IOP measurements were taken at each study visit. Primary outcome measures consisted of mean change from baseline IOP (8 AM, Noon, 4 PM) and change in visual field. Secondary measures included mean IOP, ophthalmologic examination findings, results of clinical evaluation, and adverse events. Mean change from baseline IOP at each study visit was statistically significant at all diurnal measurements for patients taking bimatoprost and for those taking latanoprost (P<.001). The 8 AM mean change from baseline IOP measurement showed a significant between-group difference (P< or =.033) in favor of bimatoprost at both follow-up visits. After 3 mo of treatment, mean IOP reductions from baseline ranged from 2.8 to 3.8 mm Hg (17.5%-21.6%) with bimatoprost and from 2.1 to 2.6 mm Hg (12.7%-16.2%) with latanoprost. Overall mean reduction in IOP after 3 mo of treatment was 3.4 mm Hg (19.9% rpar; with bimatoprost and 2.3 mm Hg (14.6%) with latanoprost (P=.035). No significant between-group differences were observed in incidence of adverse events, clinical success, or demographic variables. Bimatoprost was found to be more effective than latanoprost in lowering IOP in the patient with normal-tension glaucoma. Both drugs were efficacious and well tolerated.

The efficacy of bimatoprost 0.03% monotherapy in patients previously using topical beta-blocker monotherapy for the treatment of glaucoma or ocular hypertension.

In an open-label 12-week study, the safety and efficacy of bimatoprost 0.03% was evaluated in 55 patients with open-angle glaucoma or ocular hypertension inadequately controlled by topical beta-blocker monotherapy. Patients discontinued their topical beta-blocker therapy at the baseline visit and began bimatoprost monotherapy that evening. Study visits were at 6 and 12 weeks postbaseline. Bimatoprost reduced intraocular pressure (IOP) 4.5 mm Hg (21.5%; P < .001) from baseline at week 6 and 4.2 mm Hg (19.6%; P < .001) at week 12. Patients were more likely to achieve low target pressures with bimatoprost than with topical beta-blockers. Conjunctival hyperemia was the most commonly reported adverse event. The findings from this study indicate bimatoprost monotherapy provides a substantially greater IOP reduction than topical beta-blocker therapy and allows more patients to achieve a low target pressure. Bimatoprost is an effective alternative to topical beta-blockers for the treatment of glaucoma and ocular hypertension.

Bimatoprost 0.03% versus travoprost 0.004% in black Americans with glaucoma or ocular hypertension.

This randomized, investigator-masked, multicenter, parallel-design trial compared the IOP-lowering efficacy of bimatoprost 0.03% and travoprost 0.004% in African Americans with glaucoma or ocular hypertension. After a washout of all ocular hypotensive agents, patients were assigned to bimatoprost once daily (n=16) or travoprost once daily (n=15) for 3 months. Study visits were at baseline and at months 1, 2, and 3. Primary outcome measures were the percentage of patients who achieved selected target pressures and the mean reduction in IOP from baseline at month 3. Both drugs comparably lowered IOP, but bimatoprost was more likely than travoprost to allow achievement of every target pressure from 12 to 19 mm Hg at month 3. After 3 months, the mean IOP reduction from baseline was 8.4 mm Hg (34%) in the bimatoprost group and 7.9 mm Hg (30%) in the travoprost group. These results are being evaluated further in a larger clinical trial.

Social implications of hyperfunctional facial lines.

The face is the focus of human interactions, and facial appearance profoundly affects self-esteem. Facial appearance is not only a compilation of the dimensions of the primary morphologic features but is also a direct result of the emotional expressions exhibited on the face. Facial expressions are central in the communication of emotions, as well as in signaling characteristics such as age. The repeated expression of emotions produces hyperfunctional facial lines, and the presence of these lines when the face is at repose may give an erroneous impression of emotions or personality characteristics. These lines are also perceived as a sign of aging. Treatment of hyperfunctional facial lines is beneficial for patients who believe that their faces are not communicating their emotions properly, who want to delay the outward appearance of aging, or who simply want to look their best.

A comparison of the effect of refresh plus and bion tears on dry eye symptoms and ocular surface health in myopic LASIK patients.

PURPOSE: To compare the effect of artificial tears (0.5% carboxymethylcellulose [CMC] in lactate buffer vs. 0.3% hydroxypropyl methylcellulose and 0.1% dextran in bicarbonate buffer [HPMC]) on the preservation of ocular surface health in postoperative laser in situ keratomileusis (LASIK) patients. METHODS: Nonrandomized, comparative, retrospective analysis of a clinical database. Patients (n = 519; 985 eyes) had undergone LASIK in a single refractive surgery center performed by a single surgeon using the same LASIK technique (Nidek EC5000 laser and ACS keratome). Patients (n = 254) were given CMC (Refresh Plus/Cellufresh) or HPMC (Bion Tears) four times per day and were evaluated at presurgery, week 2, and months 1, 3, and 6. Included patients were those with complete clinical data through the month I follow-up visit. RESULTS: There were no significant between-group differences in any baseline variable. Following LASIK, fewer CMC patients (n = 111) reported dry eye symptoms than HPMC patients (n = 143) at the week 2 (13.5% vs. 30.8%; P = .001) and month 1 (19.8% vs. 38.5%; P = .001) follow-up visits. CMC patients also had significantly lower mean ocular surface staining scores than HPMC patients at week 2 (0.09 vs. 0.30; P = .015) and month 1 (0.05 vs. 0.28; P = .008). There were no between-group differences in either measure at months 3 or 6 (P < or = .728). CONCLUSIONS: CMC was more effective than HPMC in controlling dry eye symptoms and preserving ocular surface health in the immediate postoperative period in myopic post-LASIK patients, possibly due to the greater muco-adhesive properties of CMC. These results warrant further investigation as to the most effective postoperative LASIK lubricant.

Three-month comparison of brimonidine and latanoprost as adjunctive therapy in glaucoma and ocular hypertension patients uncontrolled on beta-blockers: tolerance and peak intraocular pressure lowering.

PURPOSE: To compare the tolerance and peak intraocular pressure (IOP)-lowering efficacy of brimonidine and latanoprost as adjunctive therapy in patients with ocular hypertension or glaucoma uncontrolled on beta-blockers. DESIGN: A prospective, multicenter, double-masked, parallel-design clinical trial. PARTICIPANTS: One hundred fifteen patients with IOP inadequately controlled on topical beta-blocker monotherapy. METHODS: Patients were randomly assigned to receive brimonidine, 0.2%, twice a day or latanoprost, 0.005%, every day as adjunctive therapy for 3 months. After 1 month of adjunctive treatment, patients who failed to meet a target 15% reduction in IOP at peak drug effect were crossed over to the other study medication. The target sample size of 51/group gave a power of 0.80 to detect a difference of 1 mmHg in mean IOP lowering between groups. MAIN OUTCOME MEASURES: The primary outcome variables were reduction in IOP from baseline at peak drug effect, response rate, and quality of life as measured using the Glaucoma Disability Index. RESULTS: Mean beta-blocker-treated baseline IOP was comparable between treatment groups (approximately 21.3 mm Hg). After 1 month of adjunctive therapy, brimonidine and latanoprost provided comparable IOP lowering (4.88 mmHg [22.8%] with brimonidine and 5.01 mmHg [23.5%] with latanoprost, P = 0.798). Response rates were similar in both groups, with 44 of 54 brimonidine patients and 43 of 53 latanoprost patients achieving the minimum target 15% IOP reduction at peak drug effect at month 1 (P = 0.963). Among patients who were successful at month 1 and continued on the initial study medication, mean IOP reductions were 4.55 mmHg with brimonidine and 5.49 mmHg with latanoprost (P = 0.149) at month 3. There was no significant difference in the ability of brimonidine and latanoprost to maintain at least a 15% additional reduction in IOP for 3 months (28 of 38 patients on brimonidine vs. 30 of 36 patients on latanoprost achieved > or =15% IOP reduction at month 3; P = 0.314). Patients in the latanoprost group were more likely to report negative quality-of-life variables than patients in the brimonidine group. Significantly more latanoprost patients reported watery or teary eyes (34 of 53, 64.2% vs. 23 of 54, 42.6% with brimonidine; P = 0.025) and hands and feet that became cold easily (24 of 53, 45.3% vs. 12 of 54, 22.2% with brimonidine; P = 0.012). CONCLUSIONS: As adjunct therapy with beta-blockers, brimonidine twice daily and latanoprost every day were comparable in lowering IOP at peak effect, but brimonidine was better tolerated, with fewer reports of adverse quality-of-life effects.