Phase 3 Completed N=188 Randomized Quadruple-blind Treatment

Confirmatory Study of OPC-12759 Ophthalmic Suspension

Dry Eye Syndromes

Source: ClinicalTrials.gov NCT00885079 ↗

Enrolled (actual)

188

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcomePrimary: Change in Fluorescein Corneal Staining (FCS) Score From Baseline — -3.7; -2.9 units on a scale — p=<0.05

Summary

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Fluorescein Corneal Staining (FCS) Score From Baseline	-3.7; -2.9	<0.05 sig
PRIMARY Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline	-4.5; -2.4	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Out patient
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00885079). 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.