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

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: latanoprost/timolol fixed combination drops; Drug: treatment with latanoprost/timolol fixed combination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00757835

A6219

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Travoprost/timolol therapy

Active Comparator group

Description:

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

Treatment:

Drug: treatment with latanoprost/timolol fixed combination

Drug: latanoprost/timolol fixed combination drops

Latanoprost/timolol therapy

Active Comparator group

Description:

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

Treatment:

Drug: treatment with latanoprost/timolol fixed combination

Drug: latanoprost/timolol fixed combination drops