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Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Travoprost 0.004% Ophthalmic Solution (Travatan) (Drug); Timolol 0.5% Ophthalmic Solution (Timoptic) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Summary

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0. 004% compared to Timolol 0. 5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Clinical Details

Official title: A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

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

Primary outcome:

Mean Intraocular Pressure (IOP) at 9 AM

Week 12 - Mean IOP At 4 PM

Secondary outcome:

Mean IOP Change From Baseline at 9 AM

Mean IOP Change at 4 PM

Detailed description: To evaluate the IOP lowering efficacy and safety fo Travoprost 0. 004% compared to Timolol 0. 5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥18 years;

- IOP=16-30mmHg

- OH or OAG with visual filed abnormality:

1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%, 2. Glaucoma Hemifield Test outside normal limits, 3. Corrected Pattern Standard Deviation with p <5% Exclusion Criteria:

- Previous damage of anterior chamber angle;

- ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual

Acuity (logMAR) <1. 0;

- contact lens wearer;

- severe central field loss;

- uncontrolled cardiovascular, hepatic or renal disease;

- any medication within past 1 month.

Locations and Contacts

Alcon Call Center, Fort Worth, Texas 76134, United States
Additional Information

Starting date: May 2006
Last updated: February 23, 2010

Page last updated: August 23, 2015

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