Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: travoprost 0.004% eye drops; Drug: bimatoprost 0.03% eye drops

• Registration Number: NCT00440011
• Lead Sponsor: Allergan

Brief Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-26
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2008-09-25
• Results First Submitted QC: 2008-09-25
• Results First Posted: 2008-09-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Glaucoma or ocular hypertension in both eyes
• Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering
• Best-corrected visual acuity of 20/100 or better in each eye
• Visual field within 6 months of study entry

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Exclusion Criteria

• Secondary glaucoma
• Active intraocular inflammation or macular edema
• Intraocular surgery or laser surgery within the past 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	travoprost 0.004% eye drops	-
1	bimatoprost 0.03% eye drops	-

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	Month 3	Intraocular Pressure

Secondary Outcome Measures

Name	Time	Method
Tolerability - Conjunctival Hyperemia	Month 3	Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)