N/A
Completed N=103
A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs
Source: ClinicalTrials.gov NCT00823043 ↗Enrolled (actual)
103
Serious AEs
—
Results posted
Sep 2010
Primary outcomePrimary: Subject Reported Burning/Stinging — 1.1; 2.4 Units on a Scale — p=<.001
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.
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 |
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. Informational only — not medical advice.