Dry eye syndromes
Conditions
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 keratocojunctivitis sicca; 2. Ocular hypertension or glaucoma patients 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. Patients 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 procedual medications; 9. Receipt of any investigational product within 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein corneal staining score, Lissamine green conjunctival staining score | — |
Outcome results
None listed