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

This study has been completed.

Sponsor:

Collaborator:

Alcon Research

Information provided by (Responsible Party):

AGP Konstas, Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT00444184

First received: March 5, 2007

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2007

Last Updated Date

January 25, 2013

Start Date ^ICMJE

March 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean 24-hour IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is mean 24-hour IOP.

Change History

Complete list of historical versions of study NCT00444184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean reduction from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean fluctuation of 24-hour IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Secondary endpoints are:
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.
Safety endpoints will include visual acuity, adverse events, slit lamp biomicroscopy and optic nerve assessment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: Travoprost/timolol fixed combination, travoprost

Study Arm (s)

Active Comparator: Travoprost/Timolol therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

Intervention: Drug: Travoprost/timolol fixed combination, travoprost
Active Comparator: Travoprost therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

Intervention: Drug: Travoprost/timolol fixed combination, travoprost

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

29 Years to 81 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT00444184

Other Study ID Numbers ^ICMJE

A3243

Has Data Monitoring Committee

Responsible Party

AGP Konstas, Aristotle University Of Thessaloniki

Study Sponsor ^ICMJE

Aristotle University Of Thessaloniki

Collaborators ^ICMJE

Alcon Research

Investigators ^ICMJE

Principal Investigator:

Anastasios GP Konstas, MD, PhD

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

Information Provided By

Aristotle University Of Thessaloniki

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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