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

Vistakon Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Glaucoma, Open Angle

Treatments: Drug: Timolol maleate gel forming solution; Drug: Timolol hemihydrate; Drug: Timolol Maleate in Sorbate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804648

VPH0111

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups

hemihydrate/maleate/maleate gel

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution

maleate/maleate gel/hemihydrate

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution

maleate gel/hemihydrate/maleate

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution

hemihydrate/maleate gel/maleate

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution

maleate/hemihydrate/maleate gel

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution

maleate gel, maleate, hemihydrate

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate in Sorbate

Drug: Timolol hemihydrate

Drug: Timolol maleate gel forming solution