Clinical trial NCT04669561: The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study
Official title: The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study: An Investigation on Lifitegrast's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multicenter, prospective, open label, self-controlled, single group study
Primary purpose: TREATMENT

Brief summary: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.

Detailed description: This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days

Eligibility criteria: Inclusion Criteria:

* Central or inferior corneal fluorescein staining defined by the Oxford Scale
* Reduced tear break up time (TBUT) ≤ 10 seconds.
* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.

Exclusion Criteria:

* Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes Zoster infection
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator.
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator.
* Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator.
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator.
* Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator.
* Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
* Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Primary outcomes:
measure: Change in corneal higher order aberrations
timeFrame: After 7, 14, and 28 days of treatment.
Secondary outcomes:
measure: Change in OSI after 7, 14, and 28 days of treatment.
timeFrame: After 7, 14, and 28 days of treatment.
Other outcomes:
measure: Change in best corrected visual acuity after 7, 14, and 28 days of treatment.
timeFrame: After 7, 14, and 28 days of treatment.
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
Study officials:
affiliation: Research Insight LLC
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References: