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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00471380
First received: May 8, 2007
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Intra Ocular Pressure (IOP) [ Time Frame: Baseline, end of each period (week 8, week 16, week 24) ] [ Designated as safety issue: Yes ]
    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


Enrollment: 46
Study Start Date: March 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471380

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

No publications provided

ClinicalTrials.gov Identifier: NCT00471380     History of Changes
Other Study ID Numbers: IT-04-04, EudraCT 200600362737
Study First Received: May 8, 2007
Results First Received: November 4, 2009
Last Updated: March 10, 2010
Health Authority: Agenzua Italiana del Farmaco: Italy

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Dorzolamide
Travoprost
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014