Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients.

Abstract

PURPOSE:

To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions.

METHODS:

This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01% (n=30) or bimatoprost 0.03% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test.

RESULTS:

Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01% group from baseline 4.7 ± 3.8 to 2.9 ± 2.3 (P < 0.001) and 2.5 ± 2.0 (P < 0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P = 0.003 and P < 0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01% group compared with the bimatoprost 0.03% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01% group at each follow-up visit (P < 0.05) and in comparison with bimatoprost 0.03% (P < 0.05).

CONCLUSION:

The results of this trial suggest that bimatoprost 0.01% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03% eye drops.

• Authors: M Figus, M Nardi, P Piaggi, M Sartini, G Guidi, L Martini, S Lazzeri
• Journal: Eye (London, England) (Eye (Lond)) Vol. 28 Issue 4 Pg. 422-9 (Apr 2014) ISSN: 1476-5454 [Electronic] England
• PMID: 24434659 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Amides
• Antihypertensive Agents
• Cloprostenol
• Bimatoprost

Topics

• Amides (adverse effects, therapeutic use)
• Analysis of Variance
• Antihypertensive Agents (adverse effects, therapeutic use)
• Bimatoprost
• Cloprostenol (adverse effects, analogs & derivatives, therapeutic use)
• Eye Pain (diagnosis)
• Glaucoma (drug therapy)
• Humans
• Intraocular Pressure (drug effects)
• Microscopy, Confocal
• Middle Aged
• Prospective Studies
• Tears (drug effects, metabolism)
• Visual Acuity (drug effects)