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

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

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

Conditions
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Glaucoma, Open Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Timolol Maleate in Sorbate
* Drug: Timolol hemihydrate
* Drug: Timolol maleate gel forming solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hemihydrate/maleate/maleate gel<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|
| Active Comparator: maleate/maleate gel/hemihydrate<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|
| Active Comparator: maleate gel/hemihydrate/maleate<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|
| Active Comparator: hemihydrate/maleate gel/maleate<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|
| Active Comparator: maleate/hemihydrate/maleate gel<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|
| Active Comparator: maleate gel, maleate, hemihydrate<br>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<br>* 0.5%<br>Drug: Timolol hemihydrate<br>* 0.5%<br>Drug: Timolol maleate gel forming solution<br>* 0.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | following 3 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | following 3 days of treatment | 
| Tear Film Break-up Time |  | following 3 days of treatment | 
| 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. | following 3 days of treatment | 
| Corneal Staining Count | Assessed by the investigator using a slit lamp, counting the number of spots. | following 3 days of treatment | 
| Intraoclular Pressure |  | following 3 days of treatment | 
| Basic Schirmer's | Schirmer's measures basic tear function. The higher the number, the less dry the eye. | following 3 days of treatment | 
| 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. | following 3 days of treatment | 
| Conjunctival Staining - Nasal Count | Assessed by investigator using slit lamp and counting number of spots. | following 3 days of treatment | 
| 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. | following 3 days of treatment | 
| Conjunctival Staining - Temporal Count | Assessed by investigator using a slit lamp and counting number of spots. | following 3 days of treatment | 
| 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. | following 3 days of treatment |