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Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

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ClinicalTrials.gov Identifier: NCT02138461
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
MDbackline, LLC

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

Condition or disease
Glaucoma

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.

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Study Type : Observational
Actual Enrollment : 211 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Subjective Patient Assessment Comparing Overall Tolerability and Satisfaction of a Prostaglandin Analogue Including Either Bimatoprost 0.01% or Latanoprost.
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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



Primary Outcome Measures :
  1. 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.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients taking either study medication for glaucoma.
Criteria

Inclusion Criteria:

  • Patients with glaucoma taking either bimatoprost or latanoprost

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138461


Locations
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United States, California
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Sponsors and Collaborators
MDbackline, LLC
Allergan
Investigators
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Principal Investigator: John A. Hovanesian, MD UCLA Jules Stein Eye Institute
Principal Investigator: Savak Teymoorian, MD Harvard Eye Associates
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Responsible Party: MDbackline, LLC
ClinicalTrials.gov Identifier: NCT02138461    
Other Study ID Numbers: JH-ALG-MDB-1301
First Posted: May 14, 2014    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by MDbackline, LLC:
glaucoma
bimatoprost
latanoprost
tolerability
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases