Phase 3
Completed N=209
Confirmatory Study of OPC-12759 Ophthalmic Solution
Source: ClinicalTrials.gov NCT01660256 ↗Enrolled (actual)
209
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Change in Fluorescein Corneal Staining (FCS) Score From Baseline — -3.3; -2.0; -2.9 score on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fluorescein Corneal Staining (FCS) Score From Baseline |
-3.3; -2.0; -2.9 | <0.001 sig |
| SECONDARY Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline |
-3.2; -1.7; -3.1 | <0.001 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 dry eye
- 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 (NCT01660256). 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.