dry eye syndrome
Conditions
Interventions
high-dose LT-4002 (one drop at a time, three times daily).
mid-dose LT-4002 (one drop at a time, three times daily).
low-dose LT-4002 (one drop at a time, three times daily).
placebo (one drop at a t
Sponsors
LTT Bio-Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. male and female female patients (>=20 years) 2. score of >=2 for 2 or more in 6 parameters of dry eye-related ocular symptoms and score of >= 6 for total value of 6 parameters 3. tear film break-up time (BUT) of <=5 sec 4. fluorescein-staining score of 1 or more (up to 9) 5. corrected visual acuity of greater than or equal to 0.2 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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| subjective symptoms (total value of 6 parameters: dryness, foreign body sensation, heaviness, eye pain, eye fatigue and eye discomfort) | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective symptoms (Each 12 parameters) dry eye syndrome-related QOL score (DEQS) tear film break-up time (BUT) score of fluorescein-staining score of lissamine green-staining tear volume schirmer test | — |
Countries
Japan
Contacts
Public ContactHayato Tanji
LTT Bio-Pharma Co., Ltd. Clinical Development
Outcome results
None listed