UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059716 |
|---|---|
| Receipt number | R000068298 |
| Scientific Title | A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/10 11:14:57 |
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Basic information
Public title
A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort
Acronym
A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort
Scientific Title
A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort
Scientific Title:Acronym
A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort
Region
| Japan |
Condition
Condition
Subjects who have subjective symptoms of ocular dryness and also experience eye fatigue or blurred vision.
In addition, among soft contact lens wearers, those who feel discomfort while wearing contact lenses are included.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of CHO administered as 1 to 2 drops per dose, four times daily for two weeks, in subjects with subjective symptoms of ocular dryness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the score of the subjective symptom "eye dryness"
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Over 2weeks
Interventions/Control_2
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who meet all of the following criteria 1)-4) for both eyes at the screening visit:
1)Subjects who have subjective symptoms of eye dryness (score >= 1)
2)Subjects who have subjective symptoms of eye fatigue or blurred vision (score >= 1)
3)Subjects who feel discomfort while wearing contact lenses [applicable only to soft contact lens wearers] (score >= 1)
4)Subjects who habitually wear soft contact lenses (5 days or more per week) [applicable only to soft contact lens wearers]
(2) Subjects whose mean scores for both eyes during the 3 days prior to the start of study drug administration are >= 1.0 for all of the following symptoms:
-Eye dryness
-Eye fatigue or blurred vision
-Discomfort while wearing contact lenses [applicable only to soft contact lens wearers]
Key exclusion criteria
(1) Subjects whose tear film break-up time (BUT) in either eye or both eyes is <= 5 seconds at the screening visit.
(2) Subjects who have used over-the-counter (OTC) artificial tears within 3 days prior to the start of study drug administration.
(3) Subjects who have used any ophthalmic preparations (excluding OTC artificial tears) or ophthalmic ointments within 7 days prior to the start of study drug administration.
(4) Subjects who have used corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications for ophthalmic diseases (both are administered systemically and topically to the head or face, including nasal and ear drops) within 7 days prior to the start of study drug administration.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Mantani |
Organization
ROHTO pharmaceutical CO.,LTD
Division name
Pharmaceutical Clinical Development Division
Zip code
6190216
Address
6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, JAPAN
TEL
0774-71-8802
mantani@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takeuchi |
Organization
ROHTO pharmaceutical CO.,LTD
Division name
Pharmaceutical Clinical Development Division
Zip code
6310033
Address
6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, JAPAN
TEL
09092829511
Homepage URL
takeuchiy@rohto.co.jp
Sponsor or person
Institute
ROHTO pharmaceutical CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
ROHTO pharmaceutical 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
Medical Corporation Heishinkai OPHAC Hospital IRB
Address
4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN
Tel
06-6395-9000
ophach_jinukyoku@heishinkai.com
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
| 2025 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
70
Results
Administration of CHO as 1-2 drops per dose, four times daily for two weeks, demonstrated efficacy in improving subjective symptoms such as ocular dryness and was well tolerated, indicating that it may be a useful new therapeutic option for the treatment of ocular dryness and related symptoms.
Results date posted
| 2025 | Year | 11 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age(years) at the time of consent of the 70 patients enrolled was 44.6years.
Participant flow
A total of 108 patients consented to participate in this clinical trial. Of these, 70 patients (64.8%) were eligible, and 38 patients (35.2%) were ineligible. 70 patients were enrolled, and 38 patients were unenrolled.70 patients were administered the investigational drug, 70 patients completed the treatment period, and 0 patients discontinued the study.
Adverse events
Adverse events were reported in 4 of 70 subjects (5.7%) in this clinical study. No adverse drug reactions (events with a causal relationship to the investigational product) were observed.
By preferred term (PT), the events included corneal erosion in 1 subject (1.4%), eyelid swelling in 1 subject (1.4%), eyelid pain in 1 subject (1.4%), nasopharyngitis in 1 subject (1.4%), and skin cyst in 1 subject (1.4%).
In terms of severity, one event (skin cyst) was classified as moderate. Mild adverse events consisted of corneal erosion, eyelid swelling, eyelid pain, and nasopharyngitis-one case each, for a total of 4 events in 3 subjects.
Outcome measures
Primary Endpoint:
Change in the score of the subjective symptom "dryness of the eyes."
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 01 | Month | 21 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068298
