A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-02-28

Brief Summary

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This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.

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Detailed Description

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Conditions

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Ocular Hypertension Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ganfort

Fixed combination of Bimatoprost and Timolol

Group Type ACTIVE_COMPARATOR

Ganfort

Intervention Type DRUG

Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)

Duotrav

Fixed combination of Travoprost and Timolol

Group Type ACTIVE_COMPARATOR

Duotrav

Intervention Type DRUG

Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

Interventions

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Ganfort

Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)

Intervention Type DRUG

Duotrav

Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Visual acuity 6/60 or better
2. Patients who are controlled (IOP \< 21 mmHg) on non-fixed combination of Latanoprost \& Timolol for at least 3 months before the baseline visit and
3. Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP\>21mmHG)

Exclusion Criteria

1. Angle closure glaucoma
2. Neovascular Galucoma
3. Secondary open angle glaucoma
4. Ocular infection/inflammation within 3 months
5. Ocular surgery within 3 months
6. History of Refractive surgery
7. Argon laser trabeculoplasty/Selective laser trabeculoplasty
8. Pregnancy/nursing
9. Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
10. Patients in whom beta-blockers are contraindicated
11. Patients on any drugs known to affect IOP.

Eligible Sex

ALL

Accepts Healthy Volunteers

No