Phase 2
Completed N=290
Dose-response Study of OPC-12759 Ophthalmic Suspension
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT00234078 ↗
Enrolled (actual)
290
Serious AEs
1.7%
Results posted
Feb 2014
Primary outcomePrimary: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) — -2.8; -3.1; -2.1; -2.6 scores on a scale — p=0.385
Summary
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic 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) |
-2.8; -3.1; -2.1; -2.6 | 0.385 |
| PRIMARY Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF) |
-1.2; -1.4; -1.3; -1.3 | 0.601 |
Eligibility Criteria
Inclusion Criteria
- Outpatient.
- Subjective complaint of dry eye that has been present for minimum 20 months.
- Primary ocular discomfort severity is moderate to severe.
- Corneal - conjunctival damage is moderate to severe.
- Unanesthetized Schirmer's test score of 7mm/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.
- Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
- Anticipated use of contact lens during the study.
- 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 (NCT00234078). 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.