Dry Eye
Conditions
Interventions
investigational material(s)
Generic name etc : OPC-12759 ophthalmic solution
INN of investigational material : Rebamipide
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administr
Sponsors
Otsuka Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Out patient 2. Subjective complaint of dry eye that has been present for minimum 20 months 3. Ocular discomfort severity is moderate to severe 4. Corneal - conjunctival damage is moderate to severe 5. Unanesthetized Schirmer's test score of 5mm/5minutes or less 6. Best corrected visual acuity of 0.2 or better in both eyes
Exclusion criteria
Exclusion criteria: 1. Presence of anterior segment disease or disorder other than that associated with dry eye 2. Ocular hypertension patient or glaucoma patient with ophthalmic solution 3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study 4. Anticipated use of contact lens during the study 5. Patient with punctal plug 6. Any history of ocular surgery within 12 months 7. Female patients who are pregnant,possibly pregnant or breast feeding 8. Known hypersensitivity to any component of the study drug or procedural medications 9. Receipt of any investigational product within 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Fluorescein corneal staining scores | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Lissamine green conjunctival staining scores | — |
Countries
Japan
Outcome results
None listed