Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Phase 4
Completed
- Conditions
- Ocular HypertensionGlaucoma, Open Angle
- Interventions
- Registration Number
- NCT00804648
- Lead Sponsor
- Vistakon Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description maleate/maleate gel/hemihydrate Timolol hemihydrate Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% maleate/hemihydrate/maleate gel Timolol Maleate in Sorbate Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% maleate/maleate gel/hemihydrate Timolol maleate gel forming solution Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% hemihydrate/maleate gel/maleate Timolol Maleate in Sorbate Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% maleate gel, maleate, hemihydrate Timolol maleate gel forming solution Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% maleate/maleate gel/hemihydrate Timolol Maleate in Sorbate Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% maleate/hemihydrate/maleate gel Timolol maleate gel forming solution Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% maleate gel, maleate, hemihydrate Timolol Maleate in Sorbate Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% maleate gel, maleate, hemihydrate Timolol hemihydrate Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% hemihydrate/maleate/maleate gel Timolol Maleate in Sorbate Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% hemihydrate/maleate/maleate gel Timolol maleate gel forming solution Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% maleate/hemihydrate/maleate gel Timolol hemihydrate Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% hemihydrate/maleate gel/maleate Timolol hemihydrate Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% maleate gel/hemihydrate/maleate Timolol hemihydrate Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% hemihydrate/maleate gel/maleate Timolol maleate gel forming solution Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% hemihydrate/maleate/maleate gel Timolol hemihydrate Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% maleate gel/hemihydrate/maleate Timolol Maleate in Sorbate Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% maleate gel/hemihydrate/maleate Timolol maleate gel forming solution Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
- Primary Outcome Measures
Name Time Method Stinging on Instillation 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 Outcome Measures
Name Time Method Conjunctival Hyperemia 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.
Tear Film Break-up Time following 3 days of treatment Corneal Staining Grade 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.
Corneal Staining Count following 3 days of treatment Assessed by the investigator using a slit lamp, counting the number of spots.
Intraoclular Pressure following 3 days of treatment Basic Schirmer's following 3 days of treatment Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Conjunctival Staining - Nasal Grade 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.
Conjunctival Staining - Nasal Count following 3 days of treatment Assessed by investigator using slit lamp and counting number of spots.
Visual Acuity 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.
Conjunctival Staining - Temporal Grade 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.
Conjunctival Staining - Temporal Count following 3 days of treatment Assessed by investigator using a slit lamp and counting number of spots.