A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

NCT00823043 | Completed Results

• 1 other identifier: VPH0110
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (4)

• Subject Reported Burning/Stinging

  Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  Upon instillation

• Subject Reported Tearing

  Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  Upon instillation.

• Subject Reported Light Sensitivity

  Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  Upon instillation

• Subject Reported Blurred Vision

  Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  Upon instillation

Study Arms (2)

Timolol hemihydrate

Subjects currently prescribed timolol hemihydrate 0.5% solution.

Drug: timolol hemihydrate

Timolol maleate

Subjects currently prescribed timolol maleate in sorbate.

Drug: timolol maleate

Interventions

timolol hemihydrate DRUG

timolol hemihydrate 0.5% solution

Timolol hemihydrate

timolol maleate DRUG

timolol maleate in sorbate

Timolol maleate

Eligibility Criteria

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

Study Population

The study will be performed in centers in the United States with substantial populations of patients prescribed timolol hemihydrate and timilol maleate in sorbate.

You may qualify if:

• willing to comply with investigator's and protocol's instructions
• patients signature on the informed consent document
• open-angle glaucoma or ocular hypertension
• currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

You may not qualify if:

• inability to understand the trial procedures
• inability to give informed consent
• inability to understand, read, or write English
• best corrected visual acuity of 20/200 or worse in each eye
• current moderate to severe infectious or inflammatory condition of the eye or eyelids including
• current moderate to severe dry eye syndrome
• current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
• treated with 3 or more glaucoma medicines in both eye

Sponsors & Collaborators

• Vistakon Pharmaceuticals: lead

Study Sites (1)

Eye Care of San Diego

San Diego, California, 92103, 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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 6, 2015
• Results First Posted: September 22, 2010

Record last verified: 2015-02

Locations

US (1)