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Dry EyeEarly Phase 1NCT06792903

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

A Early Phase 1 study testing YM-101 high dose + artificial tear and YM-101 low dose + artificial tear in people with Dry Eye, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
YM-101 high dose + artificial tear and YM-101 low dose + artificial tear
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
23 Apr 2024to 15 May 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all the following inclusion criteria to be enrolled in this study:
  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Punctal occlusion or surgical removal of plugs (resorbable plugs within 180 days) within 60 days before Visit 0, or plans to undergo punctal occlusion or surgical removal of plugs during the study;
  • Use of systemic immunomodulators, oral doxycycline or tetracycline within 90 days before Visit 0, or plans to use these medications irregularly during the study;
  • Local use of immunomodulators (e.g., cyclosporine A eye drops, tacrolimus eye drops) within 30 days before Visit 0;
  • Use of any medications known to cause dryness of the eyes (e.g., diuretics, antidepressants, decongestants, antispasmodics, antihistamines, anesthetics, etc.) within 30 days before Visit 0, or plans to use these medications irregularly during the study;
  • Active blepharitis or meibomian gland dysfunction and treatment for the eyes (e.g., eyelid scrubs, meibomian gland massage, wet compresses, hot compresses, systemic antibiotics, and other oral medications for ocular disease) within 30 days before Visit 0, or plans to treat irregularly during the study;
  • Use of corticosteroids or mast cell stabilizers (including ocular) within 30 days before Visit 0;
  • Use of contact lenses within 14 days before Visit 0, or plans to continue using them during the study;
  • Known allergies to test drugs or their excipients, fluorescein, or other substances involved in examination;
  • Other
  • Pregnant, nursing, or planning to become pregnant;
  • A family member residing in the same household has already been enrolled in this study or is a direct relative of staff directly involved in the management or support of this study;
  • Undergoing a drug or device trial within 30 days or 5 half-lives (whichever is longer) prior to screening, judged by the investigator to potentially affect trial results, or during the study may necessitate participation in other drug or device trials;
  • Situations that the investigator/sponsor believes may expose participants to significant risk, potentially confound trial results, seriously interfere with a participant's ability to participate in the study (e.g., language barriers, illiteracy), or not be in the best interest of the participant.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Eye & ENT hospital of Fudan University

    Shanghai, Shanghai Municipality, 20031

Other trials in China

About this study

Official title: Effectiveness and Safety of YM-101 Eye Drops in the Treatment of Dry Eye Syndrome

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.

Read the detailed description

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.

Conditions
Dry Eye
Being tested
YM-101 high dose + artificial tear, YM-101 low dose + artificial tear, placebo + artificial tear
Keywords
dry eye
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YM-101 high dose + artificial tearDrug

    Also called 2-3

    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.

  • YM-101 low dose + artificial tearDrug

    Also called 1-2

    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.

  • placebo + artificial tearDrug

    Also called 3-1

    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.

Study groups in NCT06792903
Study groupRoleWhat they receive
YM-101 high doseExperimentalPatient in this group received high dose YM-101 eyedrops in period 1 (0W to 4W) and received placebo in period 2 (8W to 12W).
Receives: Drug: YM-101 high dose + artificial tear; Drug: placebo + artificial tear
YM-101 low doseExperimentalPatient 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).
Receives: Drug: YM-101 high dose + artificial tear; Drug: YM-101 low dose + artificial tear
PlaceboPlacebo comparatorPatient 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).
Receives: Drug: YM-101 low dose + artificial tear; Drug: placebo + artificial tear

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 4

  2. 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.

    Measured: Baseline up to Week 12

  3. 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.

    Measured: Baseline up to Week 12

  4. 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).

    Measured: Baseline up to Week 12

  5. 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

    Measured: Baseline, Week 4

  6. 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.

    Measured: Baseline, Week 4

  7. 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.

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start23 Apr 2024
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792903
Sponsor's protocol ID
EyeEntFudan-YM-101
Status last verified
Mar 2026
First submitted
20 Jan 2025
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing YM-101 high dose + artificial tear and YM-101 low dose + artificial tear in people with Dry Eye, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Corneal Staining Scores at Week 4 (time frame: Baseline, Week 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06792903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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