24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

NCT ID: NCT00757835

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-03-31

Brief Summary

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Conditions

Glaucoma

Study Design

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

Study Groups

Travoprost/timolol therapy

treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.

Group Type: ACTIVE_COMPARATOR

treatment with latanoprost/timolol fixed combination

Intervention Type: DRUG

dosing in the evening with the two fixed combinations

latanoprost/timolol fixed combination drops

Intervention Type: DRUG

once in the evening

Latanoprost/timolol therapy

Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.

Group Type: ACTIVE_COMPARATOR

treatment with latanoprost/timolol fixed combination

Intervention Type: DRUG

dosing in the evening with the two fixed combinations

latanoprost/timolol fixed combination drops

Intervention Type: DRUG

once in the evening

Interventions

treatment with latanoprost/timolol fixed combination

dosing in the evening with the two fixed combinations

Intervention Type: DRUG

latanoprost/timolol fixed combination drops

once in the evening

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has XFG and is older than 29 years
• The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
• Patient can be safely washed out without risk for significant deterioration
• Distance best corrected Snelen visual acuity better than 0.1
• No contraindication to prostaglandins or β-blockers
• No history of lack of response (<10% reduction) to any medication
• Patient can understand the instructions and comply to medications
• Open normal appearing angles
• No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria

• History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
• Patient is a female of childbearing potential or lactating mother

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 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 G Konstas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Unit, 1st University Department of Ophthalmology

Other Identifiers

A6219

Identifier Type: -

Identifier Source: org_study_id