Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.