24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

NCT ID: NCT00444184

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-01-31

Brief Summary

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Travoprost/Timolol therapy

24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

Group Type: ACTIVE_COMPARATOR

Travoprost/timolol fixed combination, travoprost

Intervention Type: DRUG

Travoprost therapy

24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

Group Type: ACTIVE_COMPARATOR

Travoprost/timolol fixed combination, travoprost

Intervention Type: DRUG

Interventions

Travoprost/timolol fixed combination, travoprost

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
• Patient has POAG and is older than 29 years
• The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
• Patient can be safely washed out without risk for significant deterioration
• Distance best corrected Snellen visual acuity better than 1/10
• Patient can understand the instructions and comply to medications
• Open normal appearing angles

Exclusion Criteria

• Contraindications to prostaglandins or β-blockers
• History of lack of response (<10% reduction) to any medication
• Female of childbearing potential or lactating mother
• History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
• Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios GP Konstas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

Locations

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

A3243

Identifier Type: -

Identifier Source: org_study_id