Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138461
• Other study ID #: JH-ALG-MDB-1301
• Status: Completed
• Phase: N/A
• First received: May 9, 2014
• Last updated: September 16, 2014
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: MDbackline, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
MDbackline, LLC	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of Medications as Measured by the COMTOL Validated Instrument	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	No