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

NCT00804648 | Completed Phase 4 Results

• 1 other identifier: VPH0111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma, Open Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Conjunctival Hyperemia

  following 3 days of treatment

• Tear Film Break-up Time

  following 3 days of treatment

• Corneal Staining Grade

  following 3 days of treatment

• Corneal Staining Count

  following 3 days of treatment

• Intraoclular Pressure

  following 3 days of treatment

Study Arms (6)

hemihydrate/maleate/maleate gel

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

maleate/maleate gel/hemihydrate

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

maleate gel/hemihydrate/maleate

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

hemihydrate/maleate gel/maleate

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

maleate/hemihydrate/maleate gel

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

maleate gel, maleate, hemihydrate

ACTIVE COMPARATOR

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; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution

Interventions

Timolol Maleate in Sorbate DRUG

0.5%

hemihydrate/maleate gel/maleate; hemihydrate/maleate/maleate gel; maleate gel, maleate, hemihydrate; maleate gel/hemihydrate/maleate; maleate/hemihydrate/maleate gel; maleate/maleate gel/hemihydrate

Timolol hemihydrate DRUG

0.5%

hemihydrate/maleate gel/maleate; hemihydrate/maleate/maleate gel; maleate gel, maleate, hemihydrate; maleate gel/hemihydrate/maleate; maleate/hemihydrate/maleate gel; maleate/maleate gel/hemihydrate

Timolol maleate gel forming solution DRUG

0.5%

hemihydrate/maleate gel/maleate; hemihydrate/maleate/maleate gel; maleate gel, maleate, hemihydrate; maleate gel/hemihydrate/maleate; maleate/hemihydrate/maleate gel; maleate/maleate gel/hemihydrate

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vistakon Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Bourbonnais, Illinois, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Arthur Shedden MD
• Organization: Vistakon

904-443-1557

Study Officials

• William C. Stewart, MD

  PRN Pharmacuetical Research Network, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 6, 2015
• Results First Posted: October 20, 2010

Record last verified: 2015-02

Locations

US (2)