An Early Phase 1 interventional study of YM-101 high dose + artificial tear and YM-101 low dose + artificial tear in Dry Eye, sponsored by Eye & ENT Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Eye & ENT Hospital of Fudan University · Early Phase 1, Interventional, and Treatment
This study is a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of YM-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control.
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of YM-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control. The treatment period lasts for 84 days. Participants are randomly assigned to in randomized sequence.
There are three sequence, including sequence 1 (YM-101 high dose in period 1 switch to placebo in period 2), sequence 2 (YM-101 low dose in period 1 swich to YM-101 high dose in period 2), and sequence 3 (placebo in period 1 switch to YM-101 high dose in period 2). Period 1 starts from 0W to 4W, then washout period lasts from 4W to 8W, and period 2 starts from 8W to 12W. Participant will need to visit the clinic at 2W, 4W 8W, 10W, 12W after enrollment for checkups and tests.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
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Patients must meet all the following inclusion criteria to be enrolled in this study:
Exclusion Criteria:
**Medical History**
Blood donation or significant blood loss (more than 400 ml) within 56 days before Visit 0;
**Physical or Laboratory Examination Abnormalities**
Abnormal findings during slit-lamp and/or fundus examination during the screening period, which the investigator deems clinically significant (including but not limited to conjunctivitis, trichiasis, conjunctival laxity, glaucoma, uveitis), requiring pharmacological treatment and believed by the investigator to potentially interfere with trial results;
**Previous Medications and Treatments**
Known allergies to test drugs or their excipients, fluorescein, or other substances involved in examination;
**Other**
Patient in this group received high dose YM-101 eyedrops in period 1 (0W to 4W) and received placebo in period 2 (8W to 12W).
Drug: YM-101 high dose + artificial tear · Drug: placebo + artificial tear
Patient in this group received low dose YM-101 eyedrops in period 1 ( 0W to 4W) and received high dose YM-101 eyedrops in period 2 ( 8W to 12W).
Drug: YM-101 high dose + artificial tear · Drug: YM-101 low dose + artificial tear
Patient in this group received placebo eyedrops in period 1 (0W to 4W) and received low dose YM-101 eyedrops in period 2 (8W to 12W).
Drug: YM-101 low dose + artificial tear · Drug: placebo + artificial tear
Patient in this group received high dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive placebo YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.
Also known as: 2-3
Patient in this group received low dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive high dose YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.
Also known as: 1-2
Patient in this group received placebo dose YM-101 eyedrops twice daily and artificial tear three times a day during week 0 to week 4, after 4 week washout, patient in this group cross over to receive low dose YM-101 eyedrops twice daily and artificial tear three times a day during week 8 to week 12.
Also known as: 3-1
Change From Baseline in Corneal Staining Scores at Week 4
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 4
Percentage of Participants With Systemic Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Time frame: Baseline up to Week 12
Percentage of Participants With Ocular Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Time frame: Baseline up to Week 12
Percentage of Participants With Ocular Tolerability Assessment
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Time frame: Baseline up to Week 12
Change From Baseline in Tear Break-up Time (TBUT) at Week 4
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline
Time frame: Baseline, Week 4
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 4
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Time frame: Baseline, Week 4
Change From Baseline in Schirmer Wetting Score With Anesthesiaout at Week 4
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 4
Plan to share: Yes
Supporting information: Study protocol
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Eye & ENT Hospital of Fudan University