Safety and Efficacy of Travoprost/Timolol BAC-free

NCT00760539 | Completed Phase 3

• 1 other identifier: C-08-08
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Keywords

Glaucoma; Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure (IOP) combined across all visits and timepoints

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

  Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Travoprost/Timolol BAC-free

EXPERIMENTAL

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

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

Travoprost/Timolol

ACTIVE COMPARATOR

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

Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Interventions

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

Travoprost/Timolol BAC-free

Travoprost 0.004%/Timolol 0.5% ophthalmic solution DRUG

Also known as: DuoTrav®

Travoprost/Timolol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Manabe Clinic

Hamura, Tokyo, 205-0001, Japan

Location

MeSH Terms

Conditions

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

Interventions

Travoprost; Timolol; Ophthalmic Solutions; Duotrav

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 Officials

• Pamela Smith, B.S.

  Alcon Research

  STUDY DIRECTOR

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: September 24, 2008
• First Posted: September 26, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

JP (1)