Actively Recruiting
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
Led by Lunan Better Pharmaceutical Co., LTD. · Updated on 2025-03-17
820
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
L
Lunan Better Pharmaceutical Co., LTD.
Lead Sponsor
B
Beijing Tongren Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Lifitegrast Ophthalmic Solution for treating Dry Eye Disease (DED) in a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. This study aims to compare Lifitegrast against a placebo to better understand its potential effects on relieving symptoms and improving eye health in adults with DED. Participants will be randomly assigned to receive either Lifitegrast or a placebo eye drop. Each participant will administer one drop in each eye twice daily—morning and evening, about 12 hours apart—for 12 weeks. Both treatment groups follow the same dosing schedule during this trial period. During the study, participants will undergo regular assessments including eye dryness scoring and corneal staining tests to monitor effects after 84 days of treatment. Researchers will track symptoms, eye condition changes, and any side effects throughout the study. Participants must attend follow-up visits and adhere to the treatment and assessment schedule to support accurate evaluation of the study treatments.
CONDITIONS
Brief Title
Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and willingness to follow the trial protocol and attend follow-ups
- Age 18 years or older, any gender
- Best corrected visual acuity of 4.3 or better in both eyes at screening
- History of dry eye disease in both eyes with at least one symptom such as dryness, burning, or redness
- Use of artificial tears within 30 days before screening, with discontinuation at least 72 hours before the trial and willingness to avoid artificial tears during the study
- Total Ocular Surface Disease Index (OSDI) score of 13 or higher at screening
- Corneal fluorescein staining score of 2 or higher in at least one area of one eye at screening and baseline visits
- Conjunctival hyperemia score of 1 or higher in at least one eye at screening and baseline
- Eye Dryness Score of 40 or higher at both screening and baseline visits
- At least one eye meeting criteria for inferior corneal fluorescein staining score, Schirmer's test values at screening and baseline, with the study eye selected by defined rules
You will not qualify if you...
- Current or recent (within 30 days) ocular herpes, infection, or inflammation
- Eyelid margin abnormalities, severe conjunctivochalasis, certain corneal and ocular diseases affecting safety or results
- Ocular secondary scarring from burns or syndromes affecting compliance or assessment
- Secondary Sjögren's syndrome or autoimmune diseases unless not using immunosuppressive drugs and deemed safe
- History of organ or bone marrow transplant
- Contact lens use within 30 days prior to screening
- Physical dry eye treatments within 30 days before screening
- Use of aspirin, non-steroidal drugs, or medications causing dry eye within 30 days unless stable dose
- Use of certain ocular or systemic medications within specified timeframes before baseline
- History of punctal plug insertion or cauterization within 12 weeks
- Use of anti-glaucoma medications or glaucoma surgery within defined periods
- Recent laser capsulotomy or corneal refractive surgery within specified timeframes
- Known allergy to fluorescein or severe allergies
- Other uncontrolled clinical conditions like severe infections, hypertension, diabetes, or malignancies
- Positive pregnancy or lactation, or unwillingness to use contraception during and 1 month after the study
- Participation in other investigational trials within 30 days
- Poor compliance during placebo washout period
- Other conditions deemed unsuitable by the investigator (e.g., depression, ocular mite infection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive the study eye drops twice daily (morning and evening, approximately 12 hours apart) for the treatment of dry eye disease.
Regular visits throughout the 12-week treatment period
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Y
Ying Jie, Doctor of Philosophy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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