Phase 2
Completed N=308
Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT00475319 ↗
Enrolled (actual)
308
Serious AEs
0.3%
Results posted
Jun 2013
Primary outcomePrimary: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) — -3.5; -3.7; -1.8 FCS score — p=0.001
Summary
The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) |
-3.5; -3.7; -1.8 | 0.001 sig |
| SECONDARY Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) |
-4.0; -4.5; -1.9 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Outpatient
- Subjective complaint of dry eye that has been present for minimum 20 months
- Ocular discomfort severity is moderate to severe
- Corneal - conjunctival damage is moderate to severe
- Unanesthetized Schirmer's test score of 5mm/5minutes or less
- Best corrected visual acuity of 0.2 or better in both eyes
Exclusion Criteria
- Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
- Ocular hypertension patient or glaucoma patient with ophthalmic solution
- Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
- Anticipated use of contact lens during the study
- Patient with punctal plug
- Any history of ocular surgery within 12 months
- Female patients who are pregnant, possibly pregnant or breast feeding
- Known hypersensitivity to any component of the study drug or procedural medications
- Receipt of any investigational product within 4 months
Data sourced from ClinicalTrials.gov (NCT00475319). 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.