UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	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
Scientific Title	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
Scientific Title:Acronym	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
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 investigational product (LT-4002 or placebo) for patients with dry eye syndrome in phase 2, randomized, double-blind, placebo-controlled study (one drop at a time, three times daily for 8 weeks).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	subjective symptoms (total value of 6 parameters: dryness, foreign body sensation, heaviness, eye pain, eye fatigue and eye discomfort)
Key secondary outcomes	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

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	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	high-dose LT-4002 (one drop at a time, three times daily).
Interventions/Control_2	mid-dose LT-4002 (one drop at a time, three times daily).
Interventions/Control_3	low-dose LT-4002 (one drop at a time, three times daily).
Interventions/Control_4	placebo (one drop at a time, three times daily).
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 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
Key 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).
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Tohru Middle name Last name Mizushima
Organization	LTT Bio-Pharma Co., Ltd.
Division name	Clinical Development
Zip code	105-0022
Address	1-2-20 Kaigan, Minatoku, Tokyo
TEL	03-5733-7391
Email	t.mizushima@ltt.co.jp

Public contact
Name of contact person	1st name Hayato Middle name Last name Tanji
Organization	LTT Bio-Pharma Co., Ltd.
Division name	Clinical Development
Zip code	105-0022
Address	1-2-20 Kaigan, Minatoku, Tokyo
TEL	03-5733-7391
Homepage URL
Email	tanji@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	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Conference of Clinical Research Institutional Review Board
Address	1-13-23 Minami-Ikebukuro,Toshima-ku,Tokyo 171-0022,JAPAN
Tel	03-6868-7022
Email	jccr-info@jccr.jp

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	2019 Year 04 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 31 Day
Date of IRB	2019 Year 03 Month 28 Day
Anticipated trial start date	2019 Year 04 Month 11 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 10 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041552