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

Ocular Hypertension Clinical Trial

Official title:

A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With Timolol Hemihydrate 0.5% Solution Once or Twice Daily Versus Timolol Maleate in Sorbate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823043
• Other study ID #: VPH0110
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: February 18, 2015
• Start date: January 2009
• Est. completion date: July 2009

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: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• 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

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• timolol hemihydrate
timolol hemihydrate 0.5% solution
• timolol maleate
timolol maleate in sorbate

Locations

Country	Name	City	State
United States	Eye Care of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	No
Primary	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	No
Primary	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	No