Status:
COMPLETED
A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Alcon Research
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hyp...
Eligibility Criteria
Inclusion
- Open-angle glaucoma or confirmed ocular hypertension.
- Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \& 2.
- Sign an informed consent form.
- Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
- History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
- History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
- Severe central visual field loss in either eye.
- Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
- History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
- History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00672997
Start Date
May 1 2008
End Date
December 1 2008
Last Update
July 16 2014
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