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

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open Angle
• Intervention / Treatment: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bourbonnais, Illinois, United States
  • North Carolina
    • Charlotte, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vistakon Pharmaceuticals
• Investigators: Study Director: William C. Stewart, MD, PRN Pharmacuetical Research Network, LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 9, 2008

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Timolol; Maleic acid
• Other Study ID Numbers: VPH0111