Development of the neurotrophic keratopathy questionnaire: qualitative research.

BACKGROUND: Neurotrophic keratopathy/keratitis (NK) is a rare disease of the cornea that can lead to anatomical loss of the eye. Little is known about the NK experience from the patients' perspective. The objectives of this study were to examine the symptomatic experience and impacts of NK on patients and assess the overall comprehension, relevance, and content validity of a new questionnaire. METHODS: This was a cross-sectional, qualitative study conducted with NK patients with varying levels of disease severity, recruited from one clinical site. One-on-one interviews using concept elicitation and cognitive interviewing techniques were conducted. RESULTS: Fourteen NK patients participated; 64.3% were female (n = 9), mean age was 65.7 ± 13.3, and 14.3% (n = 2), 21.4% (n = 3), and 64.3% (n = 9) were classified as Mackie stage I, stage II, or stage III, respectively. Participants reported 24 concepts, including: redness (n = 12, 86%), sensitivity to light (n = 11, 79%), general discomfort (n = 9, 64%), dry eye (n = 9, 64%), reduced visual acuity (n = 9, 64%), blurred vision (n = 8, 57%), and eye fatigue (n = 8, 57%). No new concepts were reported after the 13th interview. The most frequently reported impacts included frustration (n = 10, 71%), driving impairment (n = 8, 57%), reading impairment (n = 7, 50%), difficulty watching television (n = 7, 50%), and concern with potentially losing their eyesight due to NK (n = 6, 43%). Participants provided positive feedback on the draft NK Questionnaire (NKQ) and felt that it was comprehensive and relevant to their experience with NK. Additionally, the recall period, instructions, item concepts, and response options were well-understood by participants. Minor revisions were made to the tool for consistency (i.e., the timeframe "in the past 7 days" was added to items 12-14); item 14 was modified to include "how often"; examples were added to item 9. CONCLUSIONS: The results of the concept elicitation portion of the qualitative study support the content validity of the draft NKQ. The clinically significant concepts identified in the literature and raised during concept elicitation are included as items in the questionnaire. Further assessment of the psychometric properties should be conducted in support of this new tool to measure the effect of new treatments on symptoms and impacts associated with NK.

Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice.

PURPOSE: The aim of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF), fixed-combination (FC) bimatoprost 0.03%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension in a clinical practice setting. PATIENTS AND METHODS: This open-label study observed patients switched to PF FC bimatoprost 0.03%/timolol 0.5% due to insufficient intraocular pressure (IOP) control on previous therapies. IOP was measured at baseline and at ~12 weeks. Tolerability and continuation of therapy were also assessed. RESULTS: A total of 1,553 patients were included in the study, and the per-protocol population comprised 1,391 patients. There were some minor deviations from protocol: some patients with no prior therapy and some who switched for reasons other than insufficient IOP control were included in the analysis. The mean IOP was reduced by 27.4%, from 22.2 mmHg to 16.1 mmHg. In subgroup analyses, the mean IOP was significantly reduced from baseline, irrespective of whether previous treatment was monotherapy or combination therapy, and preserved or PF therapy. Physicians mostly (88.1%) reported the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% to be as expected or better than expected. Switching to PF FC bimatoprost 0.03%/timolol 0.5% resulted in reductions from baseline in the number of patients reporting ocular symptoms. Adverse events were reported by 6.2% of patients, the most common being eye irritation (1.6%) and eye pruritus (1.0%). Physicians reported treatment compliance as better or unchanged compared with prior treatment in almost all patients (93.9%). Most patients were expected to continue PF FC bimatoprost 0.03%/timolol 0.5% after the end of the study. CONCLUSION: Switching to PF FC bimatoprost 0.03%/timolol 0.5% was associated with significant IOP reductions from baseline over 12 weeks. Adverse events were uncommon, and compliance was high compared with previous therapy. PF FC bimatoprost 0.03%/timolol 0.5% may be a suitable treatment for patients with inadequately controlled IOP or who are sensitive to preservatives.

A combined analysis of four observational studies evaluating the intraocular pressure-lowering ability and tolerability of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension.

OBJECTIVE: Combine and evaluate data from four clinical practice studies investigating the intraocular pressure (IOP)-lowering ability, tolerability of and patient adherence to bimatoprost 0.01% therapy in patients with primary open-angle glaucoma or ocular hypertension. METHODS: Data were combined from four multicenter, prospective, observational studies. Patients (n=2,593) were recruited from 328 sites in Austria, Belgium, Switzerland, and the Netherlands. Assessments were at study entry (baseline) and after 10-14 weeks. RESULTS: Bimatoprost 0.01% lowered mean IOP by 5.0 mmHg from baseline to final visit (P<0.0001). Individual IOP goals were achieved in 75.5% of patients. Results were similar in right and left eyes; right-eye data are presented here for brevity. The greatest mean IOP reduction was 6.7±4.7 mmHg (28.8% reduction from baseline to final visit, P<0.0001) in treatment-naïve patients. Switching to bimatoprost 0.01% monotherapy from previous monotherapy reduced mean IOP by a further 3.2±3.6 mmHg (17.2%, P<0.0001). Switching to bimatoprost 0.01% from previous prostaglandin monotherapy reduced mean IOP by 2.9±3.5 mmHg (15.5%), including by 3.1±3.4 mmHg (15.8%) and 3.3±4.1 mmHg (16.9%) for previous latanoprost and travoprost treatment, respectively (all P<0.0001). IOP reduction in patients previously treated with a fixed combination was 2.7±4.0 mmHg (14.2%, P<0.0001). The most commonly reported adverse events were conjunctival hyperemia (5.2%) and eye irritation (4.7%). Tolerability was rated as "very good" or "good" by 90.1% of patients. Adherence was rated by physicians as "better than" or "equal to" previous treatment in 97.2% of patients. CONCLUSION: The combined studies demonstrated in a clinical practice setting, bimatoprost 0.01% lowered IOP effectively in treatment-naïve and previously treated ocular hypertension and primary open-angle glaucoma patients, and was associated with good tolerability and patient adherence over 12 weeks.