UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021601 |
|---|---|
| Receipt number | 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 13:03:56 |
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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
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
t.mizushima@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024909
