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

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost ophthalmic solution (new formulation); Drug: Travoprost ophthalmic solution, 0.004%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670033

C-07-46

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 3 patient groups, including a placebo group

Travoprost new formulation

Experimental group

Description:

Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks

Treatment:

Drug: Travoprost ophthalmic solution (new formulation)

TRAVATAN

Active Comparator group

Description:

Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks

Treatment:

Drug: Travoprost ophthalmic solution, 0.004%

Vehicle

Placebo Comparator group

Description:

Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks

Treatment:

Drug: Vehicle