dry eye syndrome
Conditions
Interventions
LT-0303, t.d. for 4 weeks in both eyes
placebo, t.d. for 4 weeks in both eyes
Sponsors
LTT Bio-Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. male and female patients (>=20 years) 2. score of >=2 for 1 or more dry eye-related ocular symptoms in both eyes 3. schirmer test score of <=5 mm/5 min in both eyes and/or tear film break-up time of <=5 sec in both eyes 4. fluorescein-staining score of 3 or more (up to 9) in both eyes 5. corrected visual acuity of greater than or equal to 0.2 in both eyes. 6. patients who are able and willing to comply with all treatment and follow-up procedures. 7. patients with written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who had a history of allogeneic hematopoietic stem cell transplantation 2. Patients who had a history of refractive corneal surgery within 6 months prior to screening examination 3. Patients with contact lens use during clinical study 4. Patients who have a history of Sjogren's syndrome 5. Patients who have a history of Stevens-Johnson syndrome 6. Patients who have a history of ocular cicatricial pemphigoid 7. Patients who have a history of chemical or thermal burns 8. Patients who have a history of eye diseases other than dry eye including blepharitis, lagophthalmos, eyelid failure, iritis, pterygium and glaucoma (exceptcataract). 9. Patients who have a history of systemic disease that causes dry eye 10. Patients who have a medication use that would cause dry eyes 11. Patients who have a punctal plug or had it removed within 3 months before the screening examination 12. Patients who had a operation to the ocular surface within 12 months or intraocular surgery within the 3 months before the screening period. 13. Patients who have a history of serious hepatic, renal, or digestive disorders 14. Patients who have a history of serious hematologic disorders or cardiovascular diseases 15. Patients who have complicated malignant neoplasm such as cancer or tumor occurring within 5 years prior to informed consent 16. Patients of women in breast-feeding or of pregnant 17. Patients who participated in another clinical study within 3 months prior to informed consent 18. Patients who have a drug dependency or a history of drug abuse 19. Patients are hypersensitivity to any drug ingredients (Diclofenac Sodium, fluorescein and lissamine green, etc) 20. Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators (SIs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| score of fluorescein-staining (4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| score of lissamine green-staining tear volume schirmer test and tear film break-up time (BUT) dry eye syndrome-related QOL score (DEQS) subjective symptoms functional visual acuity | — |
Countries
Japan
Contacts
Public ContactTohru Mizushima, Ph D
LTT Bio-Pharma Co., Ltd. Chairman of Board of Directors
Outcome results
None listed