Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

Completed

• Conditions: Glaucoma

• Registration Number: NCT02138461
• Lead Sponsor: MDbackline, LLC

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2014-09-16
• Results First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Results First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability of Medications as Measured by the COMTOL Validated Instrument	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.

Trial Locations

Locations (1)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States