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 AMWeek 12 - Mean IOP At 4 PM
Secondary outcome: Mean IOP Change From Baseline at 9 AMMean 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
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