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Completed

NCT Number: NCT00823043

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

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Care of San Diego

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

timolol hemihydrate

Drug

timolol hemihydrate 0.5% solution

timolol maleate

Drug

timolol maleate in sorbate

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2009
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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