24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
Information source: Aristotle University Of Thessaloniki
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: treatment with latanoprost/timolol fixed combination (Drug); latanoprost/timolol fixed combination drops (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aristotle University Of Thessaloniki Official(s) and/or principal investigator(s):
Anastasios G Konstas, MD, PhD, Principal Investigator, Affiliation: Glaucoma Unit, 1st University Department of Ophthalmology
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Secondary outcome: Incidence of side effects with the two medications
Eligibility
Minimum age: 21 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2008
Last updated: May 9, 2014
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