UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-0303) in Patients with dry eye syndrome
Title of the study (Brief title)	Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-0303) in Patients with dry eye syndrome
Region	Japan

Condition
Condition	dry eye syndrome
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of LT-0303 for patients with dry eye syndrome in phase 2, randomized, double-blind, placebo-controlled study . (t.d. for 4 weeks)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	score of fluorescein-staining (4 weeks)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	LT-0303, t.d. for 4 weeks in both eyes
Interventions/Control_2	placebo, t.d. for 4 weeks in both eyes
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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).
Target sample size	20

Research contact person
Name of lead principal investigator	Tohru Mizushima, Ph D
Organization	LTT Bio-Pharma Co., Ltd.
Division name	Chairman of Board of Directors
Address	Shiodome Building 3F 1-2-20 Kaigan, Minatoku, Tokyo 105-0022 Japan
TEL	03-5733-7391
Email	t.mizushima@ltt.co.jp

Public contact
Name of contact person	Tohru Mizushima, Ph D
Organization	LTT Bio-Pharma Co., Ltd.
Division name	Chairman of Board of Directors
Address	Shiodome Building 3F 1-2-20 Kaigan, Minatoku, Tokyo 105-0022 Japan
TEL	03-5733-7391
Homepage URL
Email	t.mizushima@ltt.co.jp

Sponsor
Institute	LTT Bio-Pharma Co., Ltd.
Institute
Department

Funding Source
Organization	LTT Bio-Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 12 Day
Anticipated trial start date	2016 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 24 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024909