Dry eye syndromes
Conditions
Sponsors
Otsuka Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Out patient; 2.Ocular discomfort severity is moderate to severe; 3.Cornaeal-conjunctival damage is moderate to severe; 4.Unanaesthetized Schirmer's test score of 5mm/5 minutes or less, or tear breakup time is 5 seconds or less; 5.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 keratoconjunctivitis scicca; 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 procedual medications; 9.Receipt of any investigational product within 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein corneal staininig score, lissamine green conjunctive staining score | — |
Outcome results
None listed