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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804648
• Other study ID #: VPH0111
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2008
• Last updated: February 18, 2015
• Start date: November 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Timolol Maleate in Sorbate
0.5%
• Timolol hemihydrate
0.5%
• Timolol maleate gel forming solution
0.5%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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