Phase 3
N=154
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00818324 ↗Enrolled (actual)
154
Serious AEs
3.9%
Results posted
Feb 2014
Primary outcome: Primary: Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score — -2.2; -2.7; -4.1; -4.6 FCS score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-12759 Ophthalmic suspension (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score |
-2.2; -2.7; -4.1; -4.6 | <0.001 sig |
Summary
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
Eligibility Criteria
Inclusion Criteria
- Out patient;
- Ocular discomfort severity is moderate to severe;
- Corneal-conjunctival damage is moderate to severe;
- Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 scicca;
- Ocular hypertention 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 procedual medications;
- Receipt of any investigational product within 4 months.
Data sourced from ClinicalTrials.gov (NCT00818324). 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.