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Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Travoprost 0.004%/Timolol 0.5%

Latanoprost 0.005% / Timolol 0.5%

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Glaucoma, intraocular pressure, travoprost/timolol, timolol

Eligibility Criteria

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

Inclusion Criteria:

Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues.
Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit
The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point.

Exclusion Criteria:

Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy
Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
History of ocular trauma within the past 6 months.
Intraocular surgery within the past 3 months.
Ocular laser surgery within the past 3 months.
Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination.
History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
Any abnormality preventing reliable applanation tonometry.

Sites / Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Travoprost 0.004%/Timolol 0.5%

Latanoprost 0.005% / Timolol 0.5%

Arm Description

Travoprost 0.004%/Timolol 0.5%

Latanoprost 0.005% / Timolol 0.5%

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP)

Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.

Secondary Outcome Measures

Intraocular Pressure (IOP)

Mean IOP change from baseline at 9 AM at Week 2 and Week 6 visits and at 9 AM, 11 AM and 4 PM at Week 8 visit.

Full Information

NCT ID

NCT00872651

First Posted

February 25, 2009

Last Updated

March 27, 2013

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00872651

Brief Title

Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (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

Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5% once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8. Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus, cardiovascular parameters (blood pressure and pulse), and adverse events.

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, intraocular pressure, travoprost/timolol, timolol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Travoprost 0.004%/Timolol 0.5%

Arm Type

Experimental

Arm Description

Travoprost 0.004%/Timolol 0.5%

Arm Title

Latanoprost 0.005% / Timolol 0.5%

Arm Type

Active Comparator

Arm Description

Latanoprost 0.005% / Timolol 0.5%

Intervention Type

Drug

Intervention Name(s)

Travoprost 0.004%/Timolol 0.5%

Intervention Description

Travoprost 0.004%/Timolol 0.5%

Intervention Type

Drug

Intervention Name(s)

Latanoprost 0.005% / Timolol 0.5%

Intervention Description

Latanoprost 0.005% / Timolol 0.5%

Primary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Intraocular Pressure (IOP)

Description

Mean IOP change from baseline at 9 AM at Week 2 and Week 6 visits and at 9 AM, 11 AM and 4 PM at Week 8 visit.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues. Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point. Exclusion Criteria: Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension. Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study. History of ocular trauma within the past 6 months. Intraocular surgery within the past 3 months. Ocular laser surgery within the past 3 months. Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal) Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination. History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment. Any abnormality preventing reliable applanation tonometry.

Facility Information:

Facility Name

Zhongshan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

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Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

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