A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00672997

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Travoprost/Timolol BAC-free

Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks

Group Type: EXPERIMENTAL

Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution

Intervention Type: DRUG

Travoprost/Timolol

Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks

Group Type: ACTIVE_COMPARATOR

Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Interventions

Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution

Intervention Type: DRUG

Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

DuoTrav®

Eligibility Criteria

Inclusion Criteria

• Open-angle glaucoma or confirmed ocular hypertension.
• Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2.
• Sign an informed consent form.
• Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.

Exclusion Criteria

• Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
• Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
• History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
• History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
• Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
• Severe central visual field loss in either eye.
• Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
• History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
• History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Smith, B.S.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-07-64

Identifier Type: -

Identifier Source: org_study_id