ClinicalTrials.Veeva

Menu

Travoprost 3-Month Safety and Efficacy Study

Alcon logo

Alcon

Status and phase

Completed
Phase 3

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Treatments

Drug: Travoprost ophthalmic solution, 0.004%
Drug: Travoprost ophthalmic solution, 0.003%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453855
2011-004587-29 (EudraCT Number)
C-11-034

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,099 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,099 participants in 2 patient groups

Travoprost 0.003%
Experimental group
Description:
Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
Treatment:
Drug: Travoprost ophthalmic solution, 0.003%
TRAVATAN
Active Comparator group
Description:
Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Treatment:
Drug: Travoprost ophthalmic solution, 0.004%

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems