Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

September 16, 2014 updated by: MDbackline, LLC

Subjective Patient Assessment Comparing Overall Tolerability and Satisfaction of a Prostaglandin Analogue Including Either Bimatoprost 0.01% or Latanoprost.

This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients enrolled in this study completed a validated survey instrument (COMTOL) examining tolerability of topically applied ophthalmic medications that they are already taking in their regular course of care for glaucoma. The purpose of the study is to determine whether side effects and symptoms of the drugs already being taken cause problems with activities of daily living.

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients taking either study medication for glaucoma.

Description

Inclusion Criteria:

  • Patients with glaucoma taking either bimatoprost or latanoprost

Exclusion Criteria:

  • patients taking other medication or with other causes for ocular surface symptoms

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

Cohorts and Interventions

Group / Cohort
bimatoprost
These patients take bimatoprost topically for glaucoma.
latanoprost group
These patients take latanoprost topically for glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of Medications as Measured by the COMTOL Validated Instrument
Time Frame: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study
Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.
at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study

Collaborators and Investigators

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

Sponsor

MDbackline, LLC

Collaborators

Allergan

Investigators

  • Principal Investigator: John A. Hovanesian, MD, UCLA Jules Stein Eye Institute
  • Principal Investigator: Savak Teymoorian, MD, Harvard Eye Associates

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

October 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JH-ALG-MDB-1301

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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