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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00804648
First received: December 5, 2008
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Glaucoma, Open Angle
Ocular Hypertension
Drug: Timolol Maleate in Sorbate
Drug: Timolol hemihydrate
Drug: Timolol maleate gel forming solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:
  • Stinging on Instillation [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Conjunctival Hyperemia [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Tear Film Break-up Time [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
  • Corneal Staining Grade [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Corneal Staining Count [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    Assessed by the investigator using a slit lamp, counting the number of spots.

  • Intraoclular Pressure [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
  • Basic Schirmer's [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    Schirmer's measures basic tear function. The higher the number, the less dry the eye.

  • Conjunctival Staining - Nasal Grade [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Conjunctival Staining - Nasal Count [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    Assessed by investigator using slit lamp and counting number of spots.

  • Conjunctival Staining - Temporal Grade [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Conjunctival Staining - Temporal Count [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    Assessed by investigator using a slit lamp and counting number of spots.

  • Visual Acuity [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hemihydrate/maleate/maleate gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%
Active Comparator: maleate/maleate gel/hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%
Active Comparator: maleate gel/hemihydrate/maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%
Active Comparator: hemihydrate/maleate gel/maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%
Active Comparator: maleate/hemihydrate/maleate gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%
Active Comparator: maleate gel, maleate, hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
Drug: Timolol Maleate in Sorbate
0.5%
Drug: Timolol hemihydrate
0.5%
Drug: Timolol maleate gel forming solution
0.5%

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804648

Locations
United States, Illinois
Bourbonnais, Illinois, United States
United States, North Carolina
Charlotte, North Carolina, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
Study Director: William C. Stewart, MD PRN Pharmacuetical Research Network, LLC
  More Information

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00804648     History of Changes
Other Study ID Numbers: VPH0111
Study First Received: December 5, 2008
Results First Received: September 1, 2010
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Timolol
Maleic acid
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014