24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

December 16, 2020 updated by: AGP Konstas, Aristotle University Of Thessaloniki

24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has XFG and is older than 29 years
  • The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
  • Patient can be safely washed out without risk for significant deterioration
  • Distance best corrected Snelen visual acuity better than 0.1
  • No contraindication to prostaglandins or β-blockers
  • No history of lack of response (<10% reduction) to any medication
  • Patient can understand the instructions and comply to medications
  • Open normal appearing angles
  • No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria:

  • History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Patient is a female of childbearing potential or lactating mother

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Travoprost/timolol therapy
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
Drug: treatment with latanoprost/timolol fixed combination
dosing in the evening with the two fixed combinations
Drug: latanoprost/timolol fixed combination drops
once in the evening
Active Comparator: Latanoprost/timolol therapy
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
Drug: treatment with latanoprost/timolol fixed combination
dosing in the evening with the two fixed combinations
Drug: latanoprost/timolol fixed combination drops
once in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of side effects with the two medications
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Anastasios G Konstas, MD, PhD, Glaucoma Unit, 1st University Department of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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