Trial Outcomes & Findings for A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs (NCT NCT00823043)

NCT ID: NCT00823043

Last Updated: 2015-03-06

Results Overview

Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

• Recruitment status: COMPLETED
• Target enrollment: 103 participants
• Primary outcome timeframe: Upon instillation
• Results posted on: 2015-03-06

Participant Flow

Participant milestones

Measure	Timolol Hemihydrate Timolol hemihydrate 0.5% ophthalmic solution.	Timolol Maleate in Sorbate Timolol maleate in sorbate 0.5% ophthalmic solution
Overall Study STARTED	64	39
Overall Study COMPLETED	64	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

Baseline characteristics by cohort

Measure	Total Subject Population n=103 Participants All subjects responding to survey
Age, Continuous	70.7 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Upon instillation

Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Outcome measures

Measure	Timolol Hemihydrate n=64 Participants	Timolol Maleate in Sorbate n=39 Participants
Subject Reported Burning/Stinging	1.1 Units on a Scale Standard Deviation 1.1	2.4 Units on a Scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Upon instillation.

Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Outcome measures

Measure	Timolol Hemihydrate n=64 Participants	Timolol Maleate in Sorbate n=39 Participants
Subject Reported Tearing	0.9 Units on a Scale Standard Deviation 1.0	1.6 Units on a Scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Upon instillation

Population: Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.

Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Outcome measures

Measure	Timolol Hemihydrate n=63 Participants	Timolol Maleate in Sorbate n=38 Participants
Subject Reported Light Sensitivity	0.5 Units on a Scale Standard Deviation 0.7	0.4 Units on a Scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Upon instillation

Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Outcome measures

Measure	Timolol Hemihydrate n=64 Participants	Timolol Maleate in Sorbate n=39 Participants
Subject Reported Blurred Vision	0.7 Units on a Scale Standard Deviation 1.0	0.6 Units on a Scale Standard Deviation 1.0

Adverse Events

Total Subjects Surveyed

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

Arthur Shedden MD

Vistakon

Phone: 904-443-1557

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to submission for publication or presentation, the PI will provide the Sponsor with at least 60 days for review of a manuscript. If requested in writing, the PI will withhold publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER