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

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT00757835

Collaborator

Alcon Research (Industry)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: treatment with latanoprost/timolol fixed combination Drug: latanoprost/timolol fixed combination drops	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

Actual Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Travoprost/timolol therapy treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.	Drug: treatment with latanoprost/timolol fixed combination dosing in the evening with the two fixed combinations Drug: latanoprost/timolol fixed combination drops once in the evening
Active Comparator: Latanoprost/timolol therapy Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.	Drug: treatment with latanoprost/timolol fixed combination dosing in the evening with the two fixed combinations Drug: latanoprost/timolol fixed combination drops once in the evening

Arm

Intervention/Treatment

Active Comparator: Travoprost/timolol therapy

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

Drug: treatment with latanoprost/timolol fixed combination

dosing in the evening with the two fixed combinations

Drug: latanoprost/timolol fixed combination drops

once in the evening

Active Comparator: Latanoprost/timolol therapy

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

Drug: treatment with latanoprost/timolol fixed combination

dosing in the evening with the two fixed combinations

Drug: latanoprost/timolol fixed combination drops

once in the evening

Outcome Measures

Primary Outcome Measures

Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol [3 months]

Secondary Outcome Measures

Incidence of side effects with the two medications [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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