Phase 2
Completed N=102
Exploratory Study of OPC-12759 Ophthalmic Suspension
Keratoconjunctival Epithelial Disorder
Source: ClinicalTrials.gov NCT01493180 ↗
Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Mar 2014
Primary outcomePrimary: Change in the Keratoconjunctival Staining Score From Baseline — -3.4; -3.1 scores on a scale — p=0.576
Summary
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Keratoconjunctival Staining Score From Baseline |
-3.4; -3.1 | 0.576 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
- Fluorescein corneal staining score of 3 or higher
Exclusion Criteria
- Active ocular infection
- Vernal keratoconjunctivitis
- Recurrent corneal erosion
- Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
- Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
- Anticipated use of contact lens during the study.
- Insertion of punctal plug or fall out of punctal plug within 3 months
- Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
- Receipt of any investigational product within 4 months.
Data sourced from ClinicalTrials.gov (NCT01493180). 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.