Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-4002) in Patients with dry eye syndrome

Phase 2

• Conditions: dry eye syndrome

• Registration Number: JPRN-UMIN000036467
• Lead Sponsor: TT Bio-Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who had a past history of allogeneic hematopoietic stem cell transplantation 2. Patients who had a past 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 past history or present history of Sjogren's syndrome, Stevens-Johnson syndrome and ocular cicatricial pemphigoid 5. Patients who have a past history or present history of chemical or thermal burns 6. Patients who have a history of present illness of eye diseases other than dry eye including lagophthalmos, eyelid failure and pterygium 7. Patients who have a history of present illness of eye diseases other than dry eye requiring treatment or under treatment during the clinical study (including blepharitis, iritis, glaucoma and cataract) 8. Patients who have a present history of systemic disease that causes dry eye 9. Patients who have a medication use that would cause dry eyes 10. Patients who have a punctal plug or had it removed within 3 months before the screening examination 11. Patients who had a operation to the ocular surface within 12 months or intraocular surgery within the 3 months before the screening period. 12. Patients who have a present history of serious hepatic, renal, or digestive disorders 13. Patients who have a present history of serious hematologic disorders or cardiovascular diseases 14. Patients who have a past history or present history that may cause recurrence of malignant tumor 15. Patients of women in breast-feeding or of pregnant 16. Patients who participated in another clinical study within 3 months prior to informed consent 17. Patients who have a drug dependency or a history of drug abuse 18. Patients are hypersensitivity to any drug ingredients (Diclofenac Sodium, fluorescein and lissamine green, etc) 19. Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators (SIs).

Study & Design

• Study Type: Interventional
• Study Design: Not specified