Travoprost 3-Month Safety and Efficacy Study

Ocular Hypertension Clinical Trial

Official title:

A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453855
• Other study ID #: C-11-034
• Secondary ID: 2011-004587-29
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2011
• Last updated: August 13, 2013
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Description:

This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.

• Qualifying intraocular pressure at both eligibility visits.

• Understand and sign an informed consent form.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.

• Severe central visual field loss in either eye.

• Chronic, recurrent or severe inflammatory eye disease.

• Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).

• Any abnormality preventing reliable applanation tonometry.

• Hypersensitivity to prostaglandin analogs or to any component of the study medications.

• Therapy with another investigational agent within 30 days prior to the Screening Visit.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Travoprost ophthalmic solution, 0.003%

• Travoprost ophthalmic solution, 0.004%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).	Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)	No