Phase 4
N=150
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01155219 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Ocular Tolerance — 65; 34 participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Geltim LP 1 mg/g (Drug); Xalatan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratoires Thea
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Tolerance |
65; 34 | < 0.001 sig |
Summary
This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.
Eligibility Criteria
Inclusion Criteria
- Written informed consent.
- Association of the 4 following criteria:
- - Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
- - With local intolerance signs.
Exclusion Criteria
- Presence of severe objective ocular sign.
- Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
- Absolute defect in the ten degrees central point of the visual field.
- Best far corrected visual acuity ≤ 1/10.
Data sourced from ClinicalTrials.gov (NCT01155219). 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.