DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

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: Travoprost/timolol fixed combination, travoprost (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Aristotle University Of Thessaloniki

Official(s) and/or principal investigator(s):
Anastasios GP Konstas, MD, PhD, Principal Investigator, Affiliation: Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology


This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Clinical Details

Official title: A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Mean 24-hour IOP

Secondary outcome:

Mean reduction from baseline

Mean fluctuation of 24-hour IOP

Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.


Minimum age: 29 Years. Maximum age: 81 Years. Gender(s): Both.


Inclusion Criteria:

- Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean

untreated IOP greater than 23 m Hg at baseline (10: 00).

- Patient has POAG and is older than 29 years

- The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at

baseline (2 readings at 10: 00)

- Patient can be safely washed out without risk for significant deterioration

- Distance best corrected Snellen visual acuity better than 1/10

- Patient can understand the instructions and comply to medications

- Open normal appearing angles

Exclusion Criteria:

- Contraindications to prostaglandins or β-blockers

- History of lack of response (<10% reduction) to any medication

- Female of childbearing potential or lactating mother

- History of trauma, inflammation, surgery, past use of steroids (within 2 months),

severe dry eyes and use of contact lenses

- Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP

measurements etc

Locations and Contacts

Glaucoma Unit, 1st University Department of Ophthalmology, Thessaloniki 546 36, Greece
Additional Information

Starting date: March 2007
Last updated: May 9, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017