UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036467 |
|---|---|
| Receipt number | R000041552 |
| 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 |
| Date of disclosure of the study information | 2019/04/11 |
| Last modified on | 2020/03/31 15:05:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tanji@ltt.co.jp
Sponsor or person
Institute
LTT Bio-Pharma Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041552
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
