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

February 18, 2015 updated by: Vistakon Pharmaceuticals

A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With Timolol Hemihydrate 0.5% Solution Once or Twice Daily Versus Timolol Maleate in Sorbate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Eye Care of San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be performed in centers in the United States with substantial populations of patients prescribed timolol hemihydrate and timilol maleate in sorbate.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Timolol hemihydrate
Subjects currently prescribed timolol hemihydrate 0.5% solution.
Drug: timolol hemihydrate
timolol hemihydrate 0.5% solution
Timolol maleate
Subjects currently prescribed timolol maleate in sorbate.
Drug: timolol maleate
timolol maleate in sorbate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Reported Burning/Stinging
Time Frame: 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.
Upon instillation
Subject Reported Tearing
Time Frame: 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.
Upon instillation.
Subject Reported Light Sensitivity
Time Frame: 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.
Upon instillation
Subject Reported Blurred Vision
Time Frame: 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.
Upon instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vistakon Pharmaceuticals

Investigators

  • Study Director: William C. Stewart, MD, PRN Pharmacuetical Research Network, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VPH0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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