A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

travoprost 0.004% and brinzolamide 1%

fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent
Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
Stable visual field in last 6 months
6 weeks wash out from previous topical medications

Exclusion Criteria:

Age

Sites / Locations

Catania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Crossover group ABB

Crossover group BAA

Arm Description

3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)

3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).

Outcomes

Primary Outcome Measures

Intra Ocular Pressure (IOP)

Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points

Secondary Outcome Measures

Full Information

NCT ID

NCT00471380

First Posted

May 8, 2007

Last Updated

March 10, 2010

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00471380

Brief Title

A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Official Title

A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

6. Conditions and Keywords

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

Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crossover group ABB

Arm Type

Active Comparator

Arm Description

3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)

Arm Title

Crossover group BAA

Arm Type

Active Comparator

Arm Description

3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).

Intervention Type

Drug

Intervention Name(s)

travoprost 0.004% and brinzolamide 1%

Intervention Description

Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)

Intervention Type

Drug

Intervention Name(s)

fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

Intervention Description

group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).

Primary Outcome Measure Information:

Title

Intra Ocular Pressure (IOP)

Description

Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points

Time Frame

Baseline, end of each period (week 8, week 16, week 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Written informed consent Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM Stable visual field in last 6 months 6 weeks wash out from previous topical medications Exclusion Criteria: Age

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcello Fornoni

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Catania

City

Catania

ZIP/Postal Code

95123

Country

Italy

Glaucoma, Ocular Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial