Status:
COMPLETED
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Alcon Research
Conditions:
Ocular Hypertension
Open-angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypert...
Eligibility Criteria
Inclusion
- Satisfy all informed consent requirements;
- Diagnosed with open-angle glaucoma or ocular hypertension;
- Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
- IOP measurements in at least 1 eye as specified in protocol;
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
- Any form of glaucoma other than open-angle glaucoma;
- Severe central visual field loss in either eye;
- Chronic, recurrent or severe inflammatory eye disease;
- Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
- Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
- Intraocular surgery within the past 6 months;
- Ocular laser surgery within the past 3 months;
- Any abnormality preventing reliable applanation tonometry;
- Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00670033
Start Date
April 1 2008
End Date
September 1 2008
Last Update
July 10 2014
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