Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

NCT00471068 | Terminated Phase 4 Results

• 1 other identifier: EMD-05-03
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Conditions

Open-angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment

  IOP measured at week 6 minus IOP measured at baseline

  At week 0 and week 6

Study Arms (2)

Travatan

EXPERIMENTAL

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Drug: Travatan; Drug: Placebo (Timolol Vehicle)

Cosopt

ACTIVE COMPARATOR

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Drug: Cosopt

Interventions

Travatan DRUG

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Travatan

Cosopt DRUG

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Cosopt

Placebo (Timolol Vehicle) DRUG

Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Travatan

Eligibility Criteria

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

You may qualify if:

• Patient with open-angle glaucoma or ocular hypertension

You may not qualify if:

• By Age

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Coimbra

Coimbra, 3000354, Portugal

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; dorzolamide-timolol combination; Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Limitations and Caveats

Sample size smaller than the one defined by the protocol

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Labs

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Study Officials

• Anna Grau

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Last Updated: April 11, 2012
• Results First Posted: January 8, 2010

Record last verified: 2010-02

Locations

PT (1)