Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

NCT02138461 | Completed Results

• 1 other identifier: JH-ALG-MDB-1301
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

glaucoma; bimatoprost; latanoprost; tolerability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

bimatoprost

These patients take bimatoprost topically for glaucoma.

latanoprost group

These patients take latanoprost topically for glaucoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients taking either study medication for glaucoma.

You may qualify if:

• Patients with glaucoma taking either bimatoprost or latanoprost

You may not qualify if:

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

Sponsors & Collaborators

• MDbackline, LLC: lead
• Allergan: collaborator

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Biospecimen

Retention: NONE RETAINED

Note patients will be recruited to fill out a questionnaire, describing their symptoms related to glaucoma use drops. In this study, we are examining only patients taking either bimatoprost or latanoprost, thus 2 cohorts. However, this is not an interventional study, and there will be only one study visit (enrollment and questionnaire at the same time) and no change in the patient's prescribed therapy.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: John A. Hovanesian, MD
• Organization: MDbackline, LLC

jhovanesian@mdbackline.com

949 951 9248

Study Officials

• John A. Hovanesian, MD

  UCLA Jules Stein Eye Institute

  PRINCIPAL INVESTIGATOR

• Savak Teymoorian, MD

  Harvard Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 14, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)