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

Primary Purpose

Glaucoma, Open Angle, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Timolol Maleate in Sorbate
Timolol hemihydrate
Timolol maleate gel forming solution
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open Angle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

hemihydrate/maleate/maleate gel

maleate/maleate gel/hemihydrate

maleate gel/hemihydrate/maleate

hemihydrate/maleate gel/maleate

maleate/hemihydrate/maleate gel

maleate gel, maleate, hemihydrate

Arm Description

Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%

Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%

Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%

Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%

Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%

Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%

Outcomes

Primary Outcome Measures

Stinging on Instillation
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
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
Corneal Staining Grade
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
Assessed by the investigator using a slit lamp, counting the number of spots.
Intraoclular Pressure
Basic Schirmer's
Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Conjunctival Staining - Nasal Grade
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
Assessed by investigator using slit lamp and counting number of spots.
Conjunctival Staining - Temporal Grade
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
Assessed by investigator using a slit lamp and counting number of spots.
Visual Acuity
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.

Full Information

First Posted
December 5, 2008
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00804648
Brief Title
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemihydrate/maleate/maleate gel
Arm Type
Active Comparator
Arm Description
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
Arm Title
maleate/maleate gel/hemihydrate
Arm Type
Active Comparator
Arm Description
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
Arm Title
maleate gel/hemihydrate/maleate
Arm Type
Active Comparator
Arm Description
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
Arm Title
hemihydrate/maleate gel/maleate
Arm Type
Active Comparator
Arm Description
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
Arm Title
maleate/hemihydrate/maleate gel
Arm Type
Active Comparator
Arm Description
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
Arm Title
maleate gel, maleate, hemihydrate
Arm Type
Active Comparator
Arm Description
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate in Sorbate
Intervention Description
0.5%
Intervention Type
Drug
Intervention Name(s)
Timolol hemihydrate
Intervention Description
0.5%
Intervention Type
Drug
Intervention Name(s)
Timolol maleate gel forming solution
Intervention Description
0.5%
Primary Outcome Measure Information:
Title
Stinging on Instillation
Description
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.
Time Frame
following 3 days of treatment
Secondary Outcome Measure Information:
Title
Conjunctival Hyperemia
Description
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.
Time Frame
following 3 days of treatment
Title
Tear Film Break-up Time
Time Frame
following 3 days of treatment
Title
Corneal Staining Grade
Description
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.
Time Frame
following 3 days of treatment
Title
Corneal Staining Count
Description
Assessed by the investigator using a slit lamp, counting the number of spots.
Time Frame
following 3 days of treatment
Title
Intraoclular Pressure
Time Frame
following 3 days of treatment
Title
Basic Schirmer's
Description
Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Time Frame
following 3 days of treatment
Title
Conjunctival Staining - Nasal Grade
Description
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.
Time Frame
following 3 days of treatment
Title
Conjunctival Staining - Nasal Count
Description
Assessed by investigator using slit lamp and counting number of spots.
Time Frame
following 3 days of treatment
Title
Conjunctival Staining - Temporal Grade
Description
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.
Time Frame
following 3 days of treatment
Title
Conjunctival Staining - Temporal Count
Description
Assessed by investigator using a slit lamp and counting number of spots.
Time Frame
following 3 days of treatment
Title
Visual Acuity
Description
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.
Time Frame
following 3 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Stewart, MD
Organizational Affiliation
PRN Pharmacuetical Research Network, LLC
Official's Role
Study Director
Facility Information:
City
Bourbonnais
State/Province
Illinois
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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