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

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution; Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution

• Registration Number: NCT00672997
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-10
• Disposition First Submitted QC: 2014-07-10
• Disposition First Posted: 2014-07-14
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) combined across all visits and timepoints	Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit	Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).