Travoprost 3-Month Safety and Efficacy Study

NCT01453855 | Completed Phase 3 Results

• 2 other identifiers: C-11-0342011-004587-29
• Study Type: interventional
• Target: 1,099
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Travoprost 0.003%

EXPERIMENTAL

Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months

Drug: Travoprost ophthalmic solution, 0.003%

TRAVATAN

ACTIVE COMPARATOR

Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Drug: Travoprost ophthalmic solution, 0.004%

Interventions

Travoprost ophthalmic solution, 0.003% DRUG

Travoprost 0.003%

Travoprost ophthalmic solution, 0.004% DRUG

Also known as: TRAVATAN®

TRAVATAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Theresa A Landry, PhD
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Theresa A Landry, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 18, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-08