NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Dry eye
Date of first enrollment	06/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : OPC-12759E INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : Ocular administration

Outcome(s)

Primary Outcome	Efficacy, Safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion criteria 1. Males or females; 2. Out patient; 3. 20 years of age or older; 4. Subjective complaint of dry eye that has been present for minimum 20 months; 5. Primary ocular discomfort severity is moderate to severe; 6. Corneal - conjunctival damage is moderate to severe; 7. Unanesthetized Schirmer's test score of 7mm/5minutes or less; 8. Best corrected visual acuity of 0.2 or better in both eyes. Exclusion criteria 1. Presence of anterior segment disease or disorder other than that associated with keratoconjuntivitis sicca; 2. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study; 3. Anticipated use of contact lens during the study; 4. Any history of ocular surgery within 12 months ; 5. Female patients who are pregnant, possibly pregnant or breast feeding; 6. Known hypersensitivity to any component of the study drug or procedual medications; 7. Receipt of any investigational product within 4 months.
Exclude criteria