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

NCT00763061 | Completed Phase 4 Results

• 1 other identifier: MS-06-02
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Mean Intraocular Pressure (IOP) at 9 AM

  Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

  At Week 12 - At the 9 AM time point for the patient's worse eye.

• Week 12 - Mean IOP At 4 PM

  Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

  At the 4 PM time point for the patient's worse eye.

Secondary Outcomes (2)

• Mean IOP Change From Baseline at 9 AM

  Baseline to Week 12 - at 9 AM

• Mean IOP Change at 4 PM

  Baseline to Week 12 - at 4 PM

Study Arms (2)

Travoprost 0.004%

EXPERIMENTAL

Travoprost 0.004%

Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)

Timolol 0.5%

ACTIVE COMPARATOR

Timolol 0.5%

Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)

Interventions

Travoprost 0.004% Ophthalmic Solution (Travatan) DRUG

Travoprost at 9 AM + Placebo \& 9 PM

Travoprost 0.004%

Timolol 0.5% Ophthalmic Solution (Timoptic) DRUG

Timolol in each eye, twice daily at 9 AM \& 9 PM

Timolol 0.5%

Eligibility Criteria

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

You may qualify if:

• ≥18 years;
• IOP=16-30mmHg
• OH or OAG with visual filed abnormality:
• ≥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%,
• Glaucoma Hemifield Test outside normal limits,
• Corrected Pattern Standard Deviation with p \<5%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Travoprost; Ophthalmic Solutions; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 2, 2010
• Results First Posted: January 26, 2010

Record last verified: 2010-02

Locations

US (1)