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

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: timolol maleate; Drug: timolol hemihydrate

• Registration Number: NCT00823043
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-08-02
• Results First Submitted QC: 2010-08-27
• Results First Posted: 2010-09-22
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• willing to comply with investigator's and protocol's instructions
• patients signature on the informed consent document
• open-angle glaucoma or ocular hypertension
• currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

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Exclusion Criteria

• inability to understand the trial procedures
• inability to give informed consent
• inability to understand, read, or write English
• best corrected visual acuity of 20/200 or worse in each eye
• current moderate to severe infectious or inflammatory condition of the eye or eyelids including
• current moderate to severe dry eye syndrome
• current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
• treated with 3 or more glaucoma medicines in both eye

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Timolol maleate	timolol maleate	Subjects currently prescribed timolol maleate in sorbate.
Timolol hemihydrate	timolol hemihydrate	Subjects currently prescribed timolol hemihydrate 0.5% solution.

Primary Outcome Measures

Name	Time	Method
Subject Reported Burning/Stinging	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.
Subject Reported Tearing	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.
Subject Reported Light Sensitivity	Upon instillation	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.
Subject Reported Blurred Vision	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.

Trial Locations

Locations (1)

Eye Care of San Diego; 🇺🇸 San Diego, California, United States