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

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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:
Information provided by:
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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

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.).



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



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471380


Locations
Italy
Catania
Catania, Italy, 95123
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Marcello Fornoni Alcon Research

ClinicalTrials.gov Identifier: NCT00471380     History of Changes
Other Study ID Numbers: IT-04-04
EudraCT 200600362737
First Posted: May 9, 2007    Key Record Dates
Results First Posted: March 11, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Dorzolamide
Travoprost
Brinzolamide
Ophthalmic Solutions
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
Pharmaceutical Solutions