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New treatment option for Dry Eye Disease (DED)
Official title Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease
ClinicalTrials.gov ID: NCT06879782
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary participation and signing of the informed consent form, willingness to comply with the treatment regimen prescribed by the trial protocol...
- 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...
- Use of artificial tears within 30 days prior to the screening visit (V1 visit) to alleviate dry eye disease (DED) symptoms, with discontinuation of...
You likely can't join if
- Currently suffering from ocular herpes or any other ocular infection or inflammation, or having a history of ocular herpes or any other ocular...
- Presence of eyelid margin structural abnormalities (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann's nodular...
- Ocular secondary scarring (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.) that, in the investigator's...
- people with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the...
- History of organ or bone marrow transplantation.
- Wearing contact lenses within 30 days prior to screening.
See the full eligibility criteria
Who can 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...
- 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...
- Total Ocular Surface Disease Index (OSDI) score ≥13 at the screening visit (V1 visit).
- 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...
What rules you out
- 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...
- 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.
- people 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...
- History of organ or bone marrow transplantation.
- Wearing contact lenses within 30 days prior to screening.
- 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...
- 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...
- 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...
- Positive pregnancy test or lactating people (females only), or people of childbearing potential or male people with partners of childbearing potential who are unwilling to use contraception during the study and for 1...
- Participation in any other clinical trial involving investigational drugs/devices within 30 days prior to screening.
- Poor compliance during the placebo washout period (compliance \ 120%).
- Other conditions deemed unsuitable for enrollment by the investigator (e.g., depression, ocular mite infection, etc.). -
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.