N/A
N=103
A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs
Open-angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00823043 ↗Enrolled (actual)
103
Serious AEs
—
Results posted
Sep 2010
Primary outcome: Primary: Subject Reported Burning/Stinging — 1.1; 2.4 Units on a Scale — p=<.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- timolol hemihydrate (Drug); timolol maleate (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vistakon Pharmaceuticals
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Burning/Stinging |
1.1; 2.4 | <.001 sig |
| PRIMARY Subject Reported Tearing |
0.9; 1.6 | 0.024 sig |
| PRIMARY Subject Reported Light Sensitivity |
0.5; 0.4 | 0.75 |
| PRIMARY Subject Reported Blurred Vision |
0.7; 0.6 | 0.69 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00823043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.