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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014