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

Official Title: “A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension”

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

Intervention(s) in this Clinical Trial

• 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.).

Arms, Groups and Cohorts in this Clinical Trial

• 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)
• 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).

Primary Measures

• Intra Ocular Pressure (IOP)
  • Time Frame: Baseline, end of each period (week 8, week 16, week 24)
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Alcon Research Industry

Overall Clinical Trial Officials and Contacts

Marcello Fornoni Study Director Alcon Research  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471380

Study ID Number: IT-04-04

ClinicalTrials.gov Identifier: NCT00471380

Health Authority: Agenzua Italiana del Farmaco: Italy