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Dry Eye SyndromesPhase 1NCT07040826

Lifitegrast Eye Drops in Healthy Subjects：Phase I Study

A Phase 1 study testing Xiidra and Lifitegrast in people with Dry Eye Syndromes, run by Qilu Pharmaceutical Co., Ltd. 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 is a single-center, randomized, double-blind, single-dose, two-period crossover Phase I clinical trial designed to: Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears following single-dose administration in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Xiidra and Lifitegrast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
6 Dec 2022to 10 Apr 2023
Phase
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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must meet all the following criteria to be eligible:
  • Healthy, aged 18-50 (inclusive), all genders.
  • Signed informed consent pre-screening; comprehension of study and ability to complete it per protocol.
  • BMI 19-27 kg/m² (inclusive); ≥45 kg for females, ≥50 kg for males.
  • Bilateral best-corrected visual acuity ≥4.7 (5m, 5-point logMAR).
  • No reported eye discomfort/abnormalities 1 month before randomization.
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  • No history of dry eye disease, as assessed by the investigator.
  • No history of ocular inflammation (e.g., allergic conjunctivitis, uveitis) per investigator judgment.
  • Use effective contraception during study and 30 days post-last dose:
  • Females: non-pregnant, non-lactating; premenopausal use approved methods, no egg donation.
  • Males with fertile partners: vasectomy (≥30 days, no viable sperm) or approved contraception, no sperm donation.
  • Non-smoker, remain smoke-free during study.
  • No excessive alcohol (>14 units/week) or illicit drug use history; abstain from both during study.

Who cannot join

  • Subjects will be excluded if they meet any of the following:
  • History or current diseases/conditions (e.g., circulatory, endocrine disorders) that pose risks or interfere with the study, as judged by the investigator.
  • Blood donation or loss >300 mL within 56 days before randomization; no blood donation during the study.
  • Allergy to study medications (e.g., lifitegrast, excipients).
  • Prior participation in non - placebo lifitegrast clinical trials.
  • Clinically significant abnormal test results:
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  • Vital signs: ear temp >37.7℃ or <35.4℃; pulse >100 or <60 bpm; systolic BP ≥150 or <90 mmHg; diastolic BP ≥90 or <50 mmHg.
  • ECG: QTcF ≥450 ms (male), ≥460 ms (female). Lab tests: abnormal blood/urine, coagulation, infectious markers, drug/alcohol screenings.
  • Abnormal abdominal ultrasound or eye exams.
  • Intraocular/laser eye surgery within 12 months, other eye surgeries within 3 months before screening, or planned eye surgery during the study.
  • Use of ophthalmic drugs (incl. artificial tears), anticholinergics, oral/nasal steroids within 1 month before screening or during the study.
  • Tobacco/nicotine use within 6 months before randomization.
  • Contact lens use within 1 month before randomization or during the study.
  • Prescription/OTC/herbal medications within 2 weeks or 5 half - lives (longer) before randomization or during the study.
  • Pregnancy, lactation, or positive pregnancy test at screening.
  • Participation in drug/device trials within 30 days or 5 half - lives (longer) before screening, or planned participation during the study affecting results.
  • Conditions increasing risks, affecting compliance, or deemed unsuitable by the investigator (e.g., needle phobia).

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei

Other trials in China

About this study

Official title: Pharmacokinetics and Safety Study of Lifitegrast Eye Drops in Healthy Subjects - A Single-Center, Randomized, Double-Blind, Single-Dose, Two-Period Crossover Design Phase I Clinical Trial

This is a single-center, randomized, double-blind, single-dose, two-period crossover Phase I clinical trial designed to:

  • Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears following single-dose administration in healthy subjects.
  • Evaluate the safety and tolerability of Lifitegrast Ophthalmic Solution in healthy subjects.
Read more

A total of 24 healthy subjects will be randomized into two treatment sequences (Group A: T/R; Group B: R/T). The study duration per subject will be approximately 36 days, including:

  • Screening Period (Day -21 to Day -1)
  • Treatment Periods (Day 1, followed by a 7-day washout period, then Day 8 or early termination)
  • Safety Follow-up (Day 15, 7 days after the last dose).

On Day 1 of Cycle 1, one study eye will be selected and designated for all subsequent tear PK sampling. Treatment assignments:

  • Group A: Lifitegrast (T) on Day 1, then Xiidra® (R) on Day 8.
  • Group B: Xiidra® (R) on Day 1, then Lifitegrast (T) on Day 8. Each subject will receive one drop of the assigned medication (either Lifitegrast or Xiidra®) in each eye from the same single-dose container. Blood and tear samples will be collected per protocol for PK analysis, including parameters such as Cmax, AUC0-∞, AUC0-t, Tmax, T1/2, λz, and AUC_%Extrap. The PK profiles between the two treatments will be compared to evaluate bioequivalence and assess the safety of Lifitegrast Ophthalmic Solution.
Being tested
Xiidra, Lifitegrast
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.

  • XiidraDrug

    Administered on Day 1 to subjects in Group B, and on Day 8 to subjects in Group A as part of a crossover study design.

  • LifitegrastDrug

    Administered on Day 1 to subjects in Group A, and on Day 8 to subjects in Group B as part of a crossover study design.

Study groups in NCT07040826
Study groupRoleWhat they receive
Lifitegrast (T) on Day 1, then Xiidra® (R) on Day 8.ExperimentalNot described
Receives: Drug: Xiidra
Xiidra® (R) on Day 1, then Lifitegrast (T) on Day 8.ExperimentalNot described
Receives: Drug: Lifitegrast

What is being measured

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

  1. Peak Plasma Concentration (Cmax)

    Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  2. Area Under the Plasma Concentration-Time Curve (AUC0-∞)

    Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  3. Area Under the Plasma Concentration-Time Curve (AUC0-t)

    Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  4. Time to Peak Plasma Concentration (Tmax)

    Assessment: Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  5. 5. Terminal Phase Half-Life (T1/2)

    Evaluated in plasma and tears

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  6. Elimination Rate Constant (λz)

    Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.

  7. Percentage Extrapolated AUC (AUC_%Extrap)

    Evaluated in plasma and tears.

    Measured: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration

Timeline

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

  1. First posted27 Jun 2025
  2. Study start6 Dec 2022
  3. Primary completion19 Dec 2022
  4. Study completion10 Apr 2023

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
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07040826
Sponsor's protocol ID
QL-YJ1-039-101
Status last verified
Jun 2025
First submitted
18 Jun 2025
Last updated
27 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xiidra and Lifitegrast in people with Dry Eye Syndromes, run by Qilu 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 13 inclusion and 17 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 27 Jun 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Peak Plasma Concentration (Cmax) (time frame: Day 1 & Day 8: Pre-dose, 10, 20, 30, 45 minutes, and 1 hour post-administration.). 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 NCT07040826.

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 27 Jun 2025.

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