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

Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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.

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.