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24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Travoprost/timolol fixed combination, travoprost

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring travoprost/timolol fixed combination

Eligibility Criteria

29 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
Patient has POAG and is older than 29 years
The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
Patient can be safely washed out without risk for significant deterioration
Distance best corrected Snellen visual acuity better than 1/10
Patient can understand the instructions and comply to medications
Open normal appearing angles

Exclusion Criteria:

Contraindications to prostaglandins or β-blockers
History of lack of response (<10% reduction) to any medication
Female of childbearing potential or lactating mother
History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Sites / Locations

Glaucoma Unit, 1st University Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Travoprost/Timolol therapy

Travoprost therapy

Arm Description

24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

Outcomes

Primary Outcome Measures

Mean 24-hour IOP

Secondary Outcome Measures

Mean reduction from baseline

Mean fluctuation of 24-hour IOP

Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.

Full Information

NCT ID

NCT00444184

First Posted

March 5, 2007

Last Updated

May 9, 2014

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00444184

Brief Title

24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

Official Title

A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

6. Conditions and Keywords

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

Glaucoma

Keywords

travoprost/timolol fixed combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Travoprost/Timolol therapy

Arm Type

Active Comparator

Arm Description

24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

Arm Title

Travoprost therapy

Arm Type

Active Comparator

Arm Description

24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

Intervention Type

Drug

Intervention Name(s)

Travoprost/timolol fixed combination, travoprost

Primary Outcome Measure Information:

Title

Mean 24-hour IOP

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Mean reduction from baseline

Time Frame

3 months

Title

Mean fluctuation of 24-hour IOP

Time Frame

3 months

Title

Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

29 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00). Patient has POAG and is older than 29 years The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00) Patient can be safely washed out without risk for significant deterioration Distance best corrected Snellen visual acuity better than 1/10 Patient can understand the instructions and comply to medications Open normal appearing angles Exclusion Criteria: Contraindications to prostaglandins or β-blockers History of lack of response (<10% reduction) to any medication Female of childbearing potential or lactating mother History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anastasios GP Konstas, MD, PhD

Organizational Affiliation

Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Glaucoma Unit, 1st University Department of Ophthalmology

City

Thessaloniki

ZIP/Postal Code

546 36

Country

Greece

12. IPD Sharing Statement

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24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

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