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

• ClinicalTrials.gov Identifier: NCT00471380
• Recruitment Status: Completed
• First Posted: May 9, 2007
• Results First Posted: March 11, 2010
• Last Update Posted: March 16, 2010
• Sponsor: Alcon Research
• Information provided by: Alcon Research

Study Description

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

Condition or disease	Intervention/treatment	Phase
Glaucoma; Ocular Hypertension	Drug: travoprost 0.004% and brinzolamide 1%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
• Study Start Date: March 2007
• Actual Primary Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Crossover group ABB; 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)	Drug: travoprost 0.004% and brinzolamide 1%; Group A = 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.); Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle; group B = 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.).
Active Comparator: Crossover group BAA; 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).	Drug: travoprost 0.004% and brinzolamide 1%; Group A = 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.); Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle; group B = 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.).

Outcome Measures

Primary Outcome Measures :

1. Intra Ocular Pressure (IOP) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

Catania

Catania, Italy, 95123

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Marcello Fornoni; Alcon Research

More Information

• ClinicalTrials.gov Identifier: NCT00471380
• Other Study ID Numbers: IT-04-04; EudraCT 200600362737
• First Posted: May 9, 2007
• Results First Posted: March 11, 2010
• Last Update Posted: March 16, 2010
• Last Verified: March 2010

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Travoprost; Dorzolamide; Brinzolamide; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors