Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Brief Summary

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This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.

The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.

The main findings of the original trial had been published on Ophthalmology \[2007;114: 2244-2251\].

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bimatoprost

once daily

Group Type EXPERIMENTAL

Bimatoprost

Intervention Type DRUG

Latanoprost/Timolol

once daily

Group Type EXPERIMENTAL

Latanoprost/Timolol

Intervention Type DRUG

Interventions

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Bimatoprost

Intervention Type DRUG

Latanoprost/Timolol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.

Two different groups of patients were potentially eligible:

1. Those patients who were controlled (IOP\< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
2. Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP \< 21 mmHg, or, as judged by the physician, target IOP was not reached).

Pseudoexfoliation glaucomas and patients with diabetes were not excluded.

Exclusion Criteria

All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.

1. Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
2. Ocular surgery or argon laser trabeculoplasty within the last 3 months.
3. Ocular inflammation/infection occurring within 3 months before the pretrial visit.
4. Neovascular glaucomas.
5. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
6. Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
7. Patients on either bimatoprost or the LTFC.
8. Patients who had undergone refractive surgery. General
9. Inability to adhere to treatment/visit plan.
10. Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse of adequate contraception.

12\. Any drug known to affect IOP.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No