YM-101 Eye Drops in the Treatment of Dry Eye Syndrome

NCT06792903 | Completed Early Phase 1

• 1 other identifier: EyeEntFudan-YM-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Keywords

dry eye

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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).

  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

  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.

  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.

  Baseline, Week 4

Study Arms (3)

YM-101 high dose

EXPERIMENTAL

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

YM-101 low dose

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

placebo + artificial tear DRUG

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

Placebo; YM-101 high dose

YM-101 high dose + artificial tear DRUG

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

YM-101 high dose; YM-101 low dose

YM-101 low dose + artificial tear DRUG

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

Placebo; YM-101 low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, regardless of gender;
• Clearly understand and voluntarily participate in the study, with the ability and willingness to sign a written informed consent form (ICF) and comply with all study assessments and visits as instructed;
• Male and female participants of childbearing potential must agree to use medically acceptable contraception during the study and for 3 months (90 days) after the study ends. Women who are not postmenopausal or have not been menopausal for less than two years (from the last menstrual period to the signing of the ICF) must have a negative pregnancy test at Visits 0 and 1.
• A history of bilateral dry eye disease prior to the screening visit (i.e., at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision);
• Recent use (within 30 days prior to Visit 0) of artificial tears to relieve dry eye symptoms, with discontinuation of artificial tears at least 72 hours before Visit 0;
• Ocular Surface Disease Index (OSDI) total score ≥ 13 at Visit 0;
• Best corrected visual acuity ≥ 4.3 (5-point recording method on the international standard logarithmic visual acuity chart at 5 meters) in both eyes at Visit 0;
• At least one eye must have a positive corneal fluorescein staining score (CFS) at Visits 0 and 1;
• Non-anesthetic tear secretion test (SIT) ≤ 10 mm/5 min at Visits 0 and 1;
• Tear film break-up time (BUT) ≤ 10 seconds at Visits 0 and 1.

You may not qualify if:

• \*\*Medical History\*\*
• History of malignant tumors in or around the eyes;
• Dry eye formed due to scarring (e.g., radiation, alkali burns, Stevens-Johnson syndrome, scarring pemphigoid) or destruction of conjunctival goblet cells (e.g., vitamin A deficiency);
• Active ocular allergy or a history of possible ocular allergy during the study period;
• Presence of ocular or systemic infection (bacterial, viral, or fungal) at Visits 0 and 1, including fever and herpetic keratitis, or currently receiving antibiotic treatment;
• History of glaucoma diagnosis;
• History of any immunodeficiency, HIV infection, hepatitis B or C, acute active hepatitis (anti-HAV IgM positive), organ or bone marrow transplantation;
• Presence of any significant chronic diseases that the investigator considers may interfere with study parameters, including but not limited to: severe pulmonary diseases, poorly controlled hypertension, and/or poorly controlled diabetes;
• Blood donation or significant blood loss (more than 400 ml) within 56 days before Visit 0;
• \*\*Physical or Laboratory Examination Abnormalities\*\*
• Presence of active rosacea-related ocular lesions, periorbital acne, or pterygium in the eyes or eyelids;
• Anatomical abnormalities of the eyelids (e.g., eyelid laxity, entropion, or ectropion) or abnormal blinking patterns;
• 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\*\*
• Intraocular surgery or ocular laser surgery, YAG laser capsulotomy, or any surgery affecting the meibomian glands within the 180 days prior to Visit 0, or plans to undergo such surgery or treatment during the study;

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 20031, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: April 23, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)