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Safety and Efficacy of Travoprost/Timolol BAC-free

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

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

Travoprost 0.004%/Timolol 0.5% ophthalmic solution

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma, Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Manabe Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Travoprost/Timolol BAC-free

Travoprost/Timolol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit

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

Full Information

NCT ID

NCT00760539

First Posted

September 24, 2008

Last Updated

July 14, 2014

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00760539

Brief Title

Safety and Efficacy of Travoprost/Timolol BAC-free

Official Title

A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-Angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Travoprost/Timolol BAC-free

Arm Type

Experimental

Arm Description

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

Arm Title

Travoprost/Timolol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Other Intervention Name(s)

DuoTrav®

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Smith, B.S.

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Manabe Clinic

City

Hamura

State/Province

Tokyo

ZIP/Postal Code

205-0001

Country

Japan

12. IPD Sharing Statement

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Safety and Efficacy of Travoprost/Timolol BAC-free

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