Elsevier

Ophthalmology

Volume 110, Issue 3, March 2003, Pages 609-614
Ophthalmology

Effect of bimatoprost on patients with primary open-angle glaucoma or ocular hypertension who are nonresponders to latanoprost

https://doi.org/10.1016/S0161-6420(02)01891-2Get rights and content

Abstract

Purpose

To test the efficacy of bimatoprost 0.03% 2D for lowering intraocular pressure (IOP) in patients affected by primary open-angle glaucoma or ocular hypertension who did not respond to treatment with latanoprost 0.005% 2D.

Design

Prospective, randomized clinical trial with a cross over design (two 30-day treatment phases with a 30-day washout phase in between).

Participants

Fifteen patients were enrolled. Random allocation to treatment to a single eye only of every subject. Eligibility criteria: (1) IOP > 22 mmHg in both eyes on current treatment (on three separate readings > 24 hours apart), (2) angle wide open in both eyes, (3) no pseudoexfoliation and/or pigment dispersion in either eye, (4) documented medical history consistent with < 10% IOP decrease in both eyes on 2-month treatment with latanoprost 0.005% every day.

Method

The following variables were measured at each study visit: (1) IOP (Goldmann applanation tonometry, 5 readings, 8 am, 12 noon, 4 pm, 8 pm, and 12 midnight); (2) visual acuity (Early Treatment of Diabetic Retinopathy Study chart, logarithm of the minimum angle of resolution); (3) estimate of conjunctival hyperemia based on 5 standard photographs (graded as “none,” “trace,” “mild,” “moderate,” and “severe”).

Main outcome measure

IOP.

Results

IOP data (mean and standard deviation) were the following: baseline = 24.7 ± 0.9 mmHg, after washout = 24.8 ± 1.1 mmHg, after latanoprost phase = 24.1 ± 0.9 mmHg, after bimatoprost phase = 18.1 ± 1.7 mmHg. IOP on bimatoprost proved lower than both baseline (P < 0.0001) and latanoprost (P = 0.0001). Thirteen of 15 patients showed a ≥20% IOP decrease with bimatoprost treatment. None of the 15 patients showed a ≥20% decrease of IOP after 30 days of latanoprost treatment. No significant IOP changes were observed in the fellow untreated eye in each patient throughout the study. Trace-to-mild conjunctival hyperemia was recorded more often with bimatoprost phase (P = 0.035).

Conclusions

Thirteen of 15 patients, who were nonresponders to latanoprost, 0.005%, 2D, were successfully treated with bimatoprost, 0.03%, 2D. Bimatoprost treatment was associated with a higher incidence of trace-to-mild conjunctival hyperemia than latanoprost.

Section snippets

Material and methods

We searched the records of the Glaucoma Clinic of our institute to identify patients with a history of lack of response to latanoprost (i.e., ≤10% IOP lowering after 6 to 8 weeks of treatment with latanoprost, 0.005% every day). Among those identified, 15 agreed to be treated with bimatoprost and rechallenged with latanoprost in a prospective, randomized, investigator-masked crossover study. The eligibility criteria are listed in Table 1. Demographics are detailed in Table 2.

The protocol was

Results

All subjects completed the study. No significant changes in visual acuity, visual field, and corneal pachymetry were detected throughout follow-up (data not shown).

IOP data (mean and standard deviation of all measurements throughout the day) were as follows: baseline = 24.7 (0.9) mmHg; 30 days washout = 24.8 (1.1) mmHg; 30 days latanoprost = 24.1 (0.9) mmHg; 30 days bimatoprost = 18.1 (1.7) mmHg. IOP after bimatoprost was significantly lower than both the baseline IOP (P < 0.0001, paired

Discussion

We were able to identify, among the population of patients referred to our Glaucoma Service, 15 nonresponders to latanoprost 0.005% 2D. The prevalence of nonresponders to latanoprost monotherapy in human glaucomas is presently unknown. Approximately 1% of subjects enrolled in 2 major clinical trials and treated with latanoprost, 0.005% 2D, monotherapy were withdrawn because of uncontrolled IOP.1, 4 A more than 20-fold higher prevalence of nonresponders has been reported when latanoprost was

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Manuscript no. 210929.

Supported by a local grant (FIL) from the University of Parma, Parma, Italy.

The authors have no financial and/or proprietary interest in any of the products or companies mentioned in the study.

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