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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


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


Minimum age: 21 Years. Maximum age: 85 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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