Actively Recruiting
Phase III Clinical Study 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
130 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
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
Official 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 informed consent and willingness to follow study visits and treatment
- Age 18 years or older
- Best corrected visual acuity 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 prior to screening and willingness to stop use at least 72 hours before the study
- Total Ocular Surface Disease Index (OSDI) score of 13 or higher at screening
- Corneal fluorescein staining score 2 or higher in at least one region of one eye at screening and baseline visits
- Conjunctival hyperemia score of 1 or higher in at least one eye at screening and baseline visits
- Eye Dryness Score (EDS) of 40 or higher at screening and baseline visits
- At least one eye meeting criteria for Inferior Corneal Fluorescein Staining Score, Schirmer's test values at screening and baseline visits
- Selection of study eye based on specific scoring criteria if both eyes qualify
You will not qualify if you...
- Current or recent ocular herpes or other eye infections within 30 days prior to screening
- Eyelid abnormalities or severe eye surface diseases that may affect study results
- Ocular scarring conditions that may affect compliance or outcome
- Secondary Sjögren's syndrome or autoimmune diseases unless stable without certain medications
- History of organ or bone marrow transplant
- Contact lens use within 30 days prior to screening
- Physical treatments for dry eye within 30 days prior to screening
- Use of aspirin, NSAIDs, or medications causing dry eye within 30 days prior to baseline unless stable dose
- Use of certain eye or systemic medications within defined timeframes before baseline
- History of punctal plug insertion or cauterization within 12 weeks prior to screening
- Use of anti-glaucoma medications or surgery within specified periods prior to screening
- History of specific eye surgeries within defined timeframes
- Known allergies to fluorescein or severe allergic diseases
- Uncontrolled clinical conditions such as severe infections, hypertension, diabetes, or malignancies
- Positive pregnancy test, lactation, or unwillingness to use contraception during and after the study
- Participation in other clinical trials within 30 days prior to screening
- Poor compliance during placebo washout period
- Other conditions deemed unsuitable by the investigator such as depression or ocular mite infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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