UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024064 |
|---|---|
| Receipt number | R000027708 |
| Scientific Title | Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye. |
| Date of disclosure of the study information | 2016/09/16 |
| Last modified on | 2023/10/19 16:55:36 |
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Basic information
Public title
Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Acronym
Safety and efficacy of diquafosol ophthalmic solution for soft contact lens-related dry eye.
Scientific Title
Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Scientific Title:Acronym
Safety and efficacy of diquafosol ophthalmic solution for soft contact lens-related dry eye.
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Tear breakup time
corneal and conjunctival staining
subjective symptoms
contrast sensitivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diquafosol Ophthalmic Solution 3%
Interventions/Control_2
Artificial tears
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To have dry eye subjective symptoms in both eye
mean Tear break up time is less than 5 sec. or Schirmer I test is less than 5 mm (both eye)
To have corneal and conjunctival staining (both eye)
Key exclusion criteria
Patients have administration of eye drops for dry eye or steroid eye drops 14 days before start day of this study.
Patient with an infection eye disease.
Patient has a complication of an eye disease except dry eye. This complication is feared to discourage from evaluation of this study.
Patients with allergy to the ingredients used in the present study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Yamada |
Organization
Santen Pharmaceutical Co., Ltd
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9604
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical 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
Ibaraki Seinan Medical Center Hospital Ethical Review Board
Address
2190, Sakaimachi, Sashima, Ibaraki
Tel
0280-87-8111
shomu@seinan-mch.or.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
茨城西南医療センター病院/Ibaraki Seinan Medical Center Hospital
土浦協同病院なめがた地域医療センター/Tsuchiura Kyodo General Hospital Namegata District Medical Center
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12325-021-01910-8
Number of participants that the trial has enrolled
26
Results
Refer to paper
Results date posted
| 2023 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 29 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
The following adverse events were observed in this study.
Pollen allergy (both eyes)
Sinusitis
Outcome measures
Corneal staining Score
Conjunctival staining score
Tear film breakup time
Tear volume
Subjective symptoms
Visual acuity
Contrast sensitivity
Plan to share IPD
The data presented in this study are available on request from the corresponding author.
IPD sharing Plan description
The data presented in this study are available on request from the corresponding author.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027708
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