A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT00293800 | Completed Phase 3

• 1 other identifier: C-04-04
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-angle; glaucoma; ocular; hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline

  3 months

Study Arms (2)

Travoprost/Timolol

EXPERIMENTAL

One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months

Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution; Other: Timolol Vehicle

Xalatan + Timolol 0.5%

ACTIVE COMPARATOR

One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months

Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Drug: Timolol 0.5% Ophthalmic Solution

Interventions

Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Travoprost/Timolol

Latanoprost 0.005% Ophthalmic Solution (XALATAN) DRUG

Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Also known as: XALATAN

Xalatan + Timolol 0.5%

Timolol 0.5% Ophthalmic Solution DRUG

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Xalatan + Timolol 0.5%

Timolol Vehicle OTHER

Placebo

Travoprost/Timolol

Eligibility Criteria

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

You may qualify if:

• years or older.
• Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
• Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.

You may not qualify if:

• Pregnant
• History of chronic or recurrent severe inflammatory eye disease.
• History of ocular infection or ocular inflammation within the past three months in either eye.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Hypertension

Interventions

Travoprost; Timolol; Ophthalmic Solutions; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 20, 2006
• Study Start: July 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 14, 2012

Record last verified: 2012-02