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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021601
Receipt No. R000024909
Scientific 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
Date of disclosure of the study information 2016/03/25
Last modified on 2016/12/26

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Basic information
Public 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
Acronym 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
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Tohru Mizushima, Ph D
Organization LTT Bio-Pharma Co., Ltd.
Division name Chairman of Board of Directors
Zip code
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
1st name
Middle name
Last name Tohru Mizushima, Ph D
Organization LTT Bio-Pharma Co., Ltd.
Division name Chairman of Board of Directors
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 11 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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