24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

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

Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma

The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

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

29 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has open-angle glaucoma and is older than 29 years
  • Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
  • Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
  • Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
  • Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
  • Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
  • Distance best corrected Snellen visual acuity at least 0.1
  • No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
  • No history of lack of response (<10% morning IOP reduction) to any medication
  • Patient can understand the instructions and adhere to medications

Exclusion Criteria:

  • Female patient of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery
  • History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis
  • Evidence of corneal abnormality that may affect IOP measurements etc
  • Closed angle
  • History of non-compliance

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: Brinzolamide/Timolol therapy
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
Drug: Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
Other Names:
  • Combigan
Drug: Brinzolamide/timolol fixed combination drops added to travoprost
twice daily dosing
Other Names:
  • Azarga
Active Comparator: Brimonidine/Timolol therapy
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
Drug: Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
Other Names:
  • Combigan
Drug: Brinzolamide/timolol fixed combination drops added to travoprost
twice daily dosing
Other Names:
  • Azarga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean 24-hour intraocular pressure
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluctuation of 24-hour intraocular pressure
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)

August 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

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

  • A434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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