Phase 2
N=115
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
Pterygium
Bottom Line
View on ClinicalTrials.gov: NCT01109056 ↗Enrolled (actual)
115
Serious AEs
1.8%
Results posted
Jun 2012
Primary outcome: Primary: Number of Pterygium Hyperemia Responders at Week 16 — 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclosporine ophthalmic emulsion 0.05% (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pterygium Hyperemia Responders at Week 16 |
6; 8 | — |
| PRIMARY Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 |
3.1; 3.2; -0.7; -0.8 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 |
20.2; 29.3; -3.1; -10.5 | — |
Summary
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
Eligibility Criteria
Inclusion Criteria
- Have a pterygium in at least one eye that has not been previously removed with surgery
Exclusion Criteria
- Uncontrolled systemic disease
- Active eye disease
- Current or anticipated use of topical eye medications other than artificial tears.
- Anticipated wearing of contact lenses
Data sourced from ClinicalTrials.gov (NCT01109056). 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.