Phase 2 N=102 Randomized Single-blind Treatment

Exploratory Study of OPC-12759 Ophthalmic Suspension

Keratoconjunctival Epithelial Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01493180 ↗

Enrolled (actual)

102

Serious AEs

1.0%

Results posted

Mar 2014

Primary outcome: Primary: Change in the Keratoconjunctival Staining Score From Baseline — -3.4; -3.1 scores on a scale — p=0.576

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OPC-12759 ophthalmic suspension (Drug); Sodium hyaluronate ophthalmic solution (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Keratoconjunctival Staining Score From Baseline	-3.4; -3.1	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.

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.

View full record on ClinicalTrials.gov →

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.