Dry Eye Disease (DED)Phase 3NCT06879782
Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease
A Phase 3 study of Dry Eye Disease (DED), run by Lunan Better Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 28 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntary participation and signing of the informed consent form, willingness to comply with the treatment regimen prescribed by the trial protocol, and willingness to attend follow-up visits on time.
- Age ≥18 years, regardless of gender.
- Best corrected visual acuity ≥4.3 in both eyes (OU) at the screening visit (V1 visit).
- History of dry eye disease in both eyes prior to the screening visit (V1 visit) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, or fluctuating vision).
- Use of artificial tears within 30 days prior to the screening visit (V1 visit) to alleviate dry eye disease (DED) symptoms, with discontinuation of artificial tears at least 72 hours prior to the screening period, and willingness to refrain from using artificial tears during the trial.
- Total Ocular Surface Disease Index (OSDI) score ≥13 at the screening visit (V1 visit).
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- Corneal fluorescein staining score ≥2 in at least one region of at least one eye and the same eye at both the screening visit (V1 visit) and baseline visit (V2 visit).
- Conjunctival hyperemia score ≥1 in at least one eye at both V1 and V2 visits.
- Eye Dryness Score (EDS) ≥40 (VAS score, OU) at both V1 and V2 visits.
- At least one eye and the same eye meeting the following criteria at both V1 and V2 visits:
- Inferior Corneal Fluorescein Staining Score (ICSS) ≥0.5; Schirmer's test (without anesthesia) ≥1 mm and ≤10 mm.- If both eyes meet the above criteria, the eye with the higher Inferior Corneal Fluorescein Staining Score (ICSS) at the V2 visit will be selected as the study eye. If both eyes have the same ICSS at the V2 visit, the eye with the lower Schirmer's Tear Test (STT) value at the V2 visit will be designated as the study eye. If both eyes have the same ICSS and STT values at the V2 visit, the right eye will be selected as the study eye.
Who cannot join
- Currently suffering from ocular herpes or any other ocular infection or inflammation, or having a history of ocular herpes or any other ocular infection within 30 days prior to screening.
- Presence of eyelid margin structural abnormalities (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann's nodular corneal degeneration, conjunctival goblet cell damage (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, or other ocular diseases that, in the investigator's opinion, may increase the subject's risk or affect the trial results.
- Ocular secondary scarring (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.) that, in the investigator's opinion, may affect subject compliance or outcome assessment.
- Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets the following conditions: a. Not using corticosteroids, immunomodulatory, or immunosuppressive drugs for the condition; b. The investigator considers that the medical condition will not affect the trial results.
- History of organ or bone marrow transplantation.
- Wearing contact lenses within 30 days prior to screening.
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- Undergoing physical treatments for dry eye (including eyelid scrubs, meibomian gland massage, warm compresses, steam treatments, etc.) within 30 days prior to screening.
- Use of aspirin or aspirin-containing medications, non-steroidal drugs (including ocular or systemic use), or medications that may cause dry eye (e.g., anticholinergic drugs, serotonin reuptake inhibitors, etc.) within 30 days prior to the baseline visit (V2 visit), unless the subject has been on a stable dose for at least 30 days prior to the baseline visit and no change in dosage is expected during the trial.
- Use of the following medications within the specified timeframes prior to the baseline visit (V2 visit): a. Ocular or systemic antihistamines, any ocular medications: within 14 days prior to V2 visit; b. Ocular cyclosporine, tacrolimus: within 6 weeks prior to V2 visit; c. Ocular or systemic corticosteroids, mast cell stabilizers: within 14 days prior to V2 visit.
- History of punctal plug insertion or punctal cauterization within 12 weeks prior to screening.
- Use of anti-glaucoma medications within 3 months prior to screening, history of non-laser glaucoma surgery, or laser glaucoma surgery within 6 months prior to screening.
- History of YAG laser posterior capsulotomy within 6 months prior to screening, or corneal refractive surgery (e.g., LASIK) within 12 months prior to screening.
- Known allergy to fluorescein, multiple allergies, or severe allergic diseases.
- Presence of other uncontrolled clinical conditions (e.g., severe chronic infections, severe cardiopulmonary diseases, uncontrolled hypertension [defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite antihypertensive treatment], uncontrolled diabetes, malignancies, etc.).
- Positive pregnancy test or lactating subjects (females only), or subjects of childbearing potential or male subjects with partners of childbearing potential who are unwilling to use contraception during the study and for 1 month after the last dose of study medication.
- Participation in any other clinical trial involving investigational drugs/devices within 30 days prior to screening.
- Poor compliance during the placebo washout period (compliance <80% or >120%).
- Other conditions deemed unsuitable for enrollment by the investigator (e.g., depression, ocular mite infection, etc.). -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Ying Jie, 86-010-58269675, jie_yingcn@aliyun.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study on the Efficacy and Safety of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Drug placebo
- Keywords
- Lifitegrast，Dry eye disease (DED)
- 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.
Drug placeboDrug
Also called Lifitegrast, Placebo
Instill one drop of the eye solution in each eye, twice a day (morning and evening, approximately 12 hours apart), for a treatment period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lifitegrast | Experimental | Administer one drop of the ophthalmic solution in each eye, twice daily (morning and evening, approximately 12 hours apart), for a duration of 12 weeks. Receives: Drug: Drug placebo |
| placebo | Placebo comparator | Administer one drop of the ophthalmic solution in each eye, twice daily (morning and evening, approximately 12 hours apart), for a duration of 12 weeks. Receives: Drug: Drug placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior Corneal Fluorescein Staining Score
After 84 days of treatment, the mean change from baseline in the Inferior Corneal Fluorescein Staining Score (ICSS，0-4) in the treatment group was compared with that in the placebo group. A higher corneal fluorescein staining score indicates a worse condition
Measured: After 84 days of treatment
Eye Dryness Score
After 84 days of treatment, the mean change from baseline in the Eye Dryness Score (EDS, 0-100 [VAS, Visual Analog Scale]) in the treatment group was compared with that in the placebo group.A higher Eye Dryness Score indicates a worse condition.
Measured: After 84 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start28 Mar 2024
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879782
- Sponsor's protocol ID
- BT-LTST-ED-Ⅲ
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study on the Efficacy and Safety of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT06879782
- Acronym / sponsor ID
- BT-LTST-ED-Ⅲ
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Lifitegrast，Dry eye disease (DED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tongren Hospital
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifitegrast | Experimental | Drug: Drug placeboAdminister one drop of the ophthalmic solution in each eye, twice daily (morning and evening, approximately 12 hours apart), for a duration of 12 weeks. |
| placebo | Placebo comparator | Drug: Drug placeboAdminister one drop of the ophthalmic solution in each eye, twice daily (morning and evening, approximately 12 hours apart), for a duration of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary participation and signing of the informed consent form, willingness to comply with the treatment regimen prescribed by the trial protocol, and willingness to attend follow-up visits on time.
- Age ≥18 years, regardless of gender.
- Best corrected visual acuity ≥4.3 in both eyes (OU) at the screening visit (V1 visit).
- History of dry eye disease in both eyes prior to the screening visit (V1 visit) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, or fluctuating vision).
- Use of artificial tears within 30 days prior to the screening visit (V1 visit) to alleviate dry eye disease (DED) symptoms, with discontinuation of artificial tears at least 72 hours prior to the screening period, and willingness to refrain from using artificial tears during the trial.
Key exclusion criteria (18 listed)
- Currently suffering from ocular herpes or any other ocular infection or inflammation, or having a history of ocular herpes or any other ocular infection within 30 days prior to screening.
- Presence of eyelid margin structural abnormalities (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann's nodular corneal degeneration, conjunctival goblet cell damage (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, or other ocular diseases that, in the investigator's opinion, may increase the subject's risk or affect the trial results.
- Ocular secondary scarring (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.) that, in the investigator's opinion, may affect subject compliance or outcome assessment.
- Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets the following conditions: a. Not using corticosteroids, immunomodulatory, or immunosuppressive drugs for the condition; b. The investigator considers that the medical condition will not affect the trial results.
- History of organ or bone marrow transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug placeboAlso: Lifitegrast, PlaceboInstill one drop of the eye solution in each eye, twice a day (morning and evening, approximately 12 hours apart), for a treatment period of 12 weeks. | Drug | Lifitegrast, placebo |
Primary outcome
Inferior Corneal Fluorescein Staining Score
Time frame: After 84 days of treatment
After 84 days of treatment, the mean change from baseline in the Inferior Corneal Fluorescein Staining Score (ICSS，0-4) in the treatment group was compared with that in the placebo group. A higher corneal fluorescein staining score indicates a worse condition
Eye Dryness Score
Time frame: After 84 days of treatment
After 84 days of treatment, the mean change from baseline in the Eye Dryness Score (EDS, 0-100 [VAS, Visual Analog Scale]) in the treatment group was compared with that in the placebo group.A higher Eye Dryness Score indicates a worse condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Dry Eye Disease (DED), run by Lunan Better Pharmaceutical Co., LTD. 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 18 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Jie, Doctor of Philosophy (86-010-58269675, jie_yingcn@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inferior Corneal Fluorescein Staining Score (time frame: After 84 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.