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Completed

NCT Number: NCT00804648

Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bourbonnais, Illinois, United States

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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
  • primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
  • at screening intraocular pressure must be considered to be safe, in both eyes
  • in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
  • currently treated with one glaucoma medication, untreated intraocular pressure of less than or equal to 28 mm Hg at visit 2 in both eyes

Exclusion criteria

  • any abnormality preventing reliable applanation tonometry in either eye
  • any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
  • any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
  • any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
  • females of childbearing potential not using reliable means of birth control
  • pregnant or lactating females
  • any clinically significant, serious, or severe medical or psychiatric condition
  • participation (or current participation) in any investigational drug or device trial within 30 days prior to Visit 1
  • severe prior visual acuity or field loss from any cause
  • inability to understand the trial procedures, and thus inability to give informed consent
  • progressive retinal or optic nerve disease apart from glaucoma
  • serious systemic or ocular disease
  • intraocular laser surgery within the past three months or corneal or intraocular conventional surgery within the past 6 months
  • concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic route.
  • subjects requiring tear replacement drops or allergy medications with sympathomimetics 24 hours prior to a scheduled study visit
  • contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
  • any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial

Treatment and study plan

Timolol Maleate in Sorbate

Drug

0.5%

timolol hemihydrate

Drug

0.5%

Timolol maleate gel forming solution

Drug

0.5%

Primary outcomes

  1. Stinging on Instillation

    Time frame: following 3 days of treatment

    Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.

Secondary outcomes

  1. Conjunctival Hyperemia

    Time frame: following 3 days of treatment

    Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.

  2. Tear Film Break-up Time

    Time frame: following 3 days of treatment

  3. Corneal Staining Grade

    Time frame: following 3 days of treatment

    Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.

  4. Corneal Staining Count

    Time frame: following 3 days of treatment

    Assessed by the investigator using a slit lamp, counting the number of spots.

  5. Intraoclular Pressure

    Time frame: following 3 days of treatment

  6. Basic Schirmer's

    Time frame: following 3 days of treatment

    Schirmer's measures basic tear function. The higher the number, the less dry the eye.

  7. Conjunctival Staining - Nasal Grade

    Time frame: following 3 days of treatment

    Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.

  8. Conjunctival Staining - Nasal Count

    Time frame: following 3 days of treatment

    Assessed by investigator using slit lamp and counting number of spots.

  9. Conjunctival Staining - Temporal Grade

    Time frame: following 3 days of treatment

    Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.

  10. Conjunctival Staining - Temporal Count

    Time frame: following 3 days of treatment

    Assessed by investigator using a slit lamp and counting number of spots.

  11. Visual Acuity

    Time frame: following 3 days of treatment

    The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Official study title

Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 9, 2008
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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