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

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Alcon

Status and phase

Completed
Phase 4

Conditions

Glaucoma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00763061
MS-06-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

111 participants in 2 patient groups

Travoprost 0.004%
Experimental group
Description:
Travoprost 0.004%
Treatment:
Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
Timolol 0.5%
Active Comparator group
Description:
Timolol 0.5%
Treatment:
Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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