Phase 4
N=30
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00804648 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Stinging on Instillation — 0.6; 1.0; 0.6 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Timolol Maleate in Sorbate (Drug); Timolol hemihydrate (Drug); Timolol maleate gel forming solution (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vistakon Pharmaceuticals
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stinging on Instillation |
0.6; 1.0; 0.6 | — |
| SECONDARY Conjunctival Hyperemia |
0.2; 0.4; 0.3 | — |
| SECONDARY Tear Film Break-up Time |
8.5; 7.7; 8.5 | — |
| SECONDARY Corneal Staining Grade |
1.2; 1.1; 1.0 | — |
| SECONDARY Corneal Staining Count |
10.5; 10.4; 8.3 | — |
| SECONDARY Intraoclular Pressure |
16.3; 16.2; 16.2 | — |
| SECONDARY Basic Schirmer's |
17.7; 14.8; 15.4 | — |
| SECONDARY Conjunctival Staining - Nasal Grade |
1.2; 1.1; 1.3 | — |
| SECONDARY Conjunctival Staining - Nasal Count |
11.0; 10.3; 12.9 | — |
| SECONDARY Conjunctival Staining - Temporal Grade |
0.8; 0.7; 0.8 | — |
| SECONDARY Conjunctival Staining - Temporal Count |
4.7; 4.8; 5.3 | — |
| SECONDARY Visual Acuity |
52.3; 52.5; 51.4 | — |
Summary
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
- any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial
Data sourced from ClinicalTrials.gov (NCT00804648). 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.