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

NCT00471380 | Completed Phase 4 Results

• 2 other identifiers: IT-04-04EudraCT 200600362737
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intra Ocular Pressure (IOP)

  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

  Baseline, end of each period (week 8, week 16, week 24)

Study Arms (2)

Crossover group ABB

ACTIVE COMPARATOR

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%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

Crossover group BAA

ACTIVE COMPARATOR

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%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

Interventions

travoprost 0.004% and brinzolamide 1% DRUG

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.)

Crossover group ABB; Crossover group BAA

fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle DRUG

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.).

Crossover group ABB; Crossover group BAA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• weeks wash out from previous topical medications

You may not qualify if:

• Age

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Catania

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Travoprost; dorzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Research, LTD

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Study Officials

• Marcello Fornoni

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Last Updated: March 16, 2010
• Results First Posted: March 11, 2010

Record last verified: 2010-03

Locations

IT (1)