Trial Outcomes & Findings for Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops (NCT NCT02138461)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

211 participants

Primary outcome timeframe

at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study

Results posted on

2014-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost These patients take bimatoprost topically for glaucoma.	Latanoprost Group These patients take latanoprost topically for glaucoma.
Overall Study STARTED	101	110
Overall Study COMPLETED	101	110
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost n=101 Participants These patients take bimatoprost topically for glaucoma.	Latanoprost Group n=110 Participants These patients take latanoprost topically for glaucoma.	Total n=211 Participants Total of all reporting groups
Age, Continuous	75.3 years STANDARD_DEVIATION 12.0 • n=5 Participants	73.4 years STANDARD_DEVIATION 12.1 • n=7 Participants	74.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	56 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	54 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants	110 participants n=7 Participants	211 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bimatoprost n=101 Participants These patients take bimatoprost topically for glaucoma.	Latanoprost Group n=110 Participants These patients take latanoprost topically for glaucoma.
Tolerability of Medications as Measured by the COMTOL Validated Instrument Bothered by Itching More than "A Little"	23 percentage of patients	50 percentage of patients
Tolerability of Medications as Measured by the COMTOL Validated Instrument Bothered by Burning/Stinging More Than "A Little"	26 percentage of patients	29 percentage of patients
Tolerability of Medications as Measured by the COMTOL Validated Instrument Bothered by Redness More Than "A Little"	31 percentage of patients	42 percentage of patients
Tolerability of Medications as Measured by the COMTOL Validated Instrument Bothered by Dry Eyes More Than "A Little"	47 percentage of patients	54 percentage of patients

Adverse Events

Bimatoprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Latanoprost Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John A. Hovanesian, MD

MDbackline, LLC

Phone: 949 951 9248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place