A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: travoprost 0.004% and brinzolamide 1%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

• Registration Number: NCT00471380
• Lead Sponsor: Alcon Research

Brief Summary

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-09
• Primary Completion: 2008-10
• Results First Submitted: 2009-11-04
• Results First Submitted QC: 2010-02-24
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-10
• Results First Posted: 2010-03-11
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Written informed consent
• Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
• Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
• Stable visual field in last 6 months
• 6 weeks wash out from previous topical medications

Exclusion Criteria

• Age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover group ABB	travoprost 0.004% and brinzolamide 1%	3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
Crossover group BAA	travoprost 0.004% and brinzolamide 1%	3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
Crossover group ABB	fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle	3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
Crossover group BAA	fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle	3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).

Primary Outcome Measures

Name	Time	Method
Intra Ocular Pressure (IOP)	Baseline, end of each period (week 8, week 16, week 24)	Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points

Trial Locations

Locations (1)

Catania; 🇮🇹 Catania, Italy