The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study (CLEAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Lifitegrast 5% Ophthalmic Solution

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye & Associates
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single /arm; All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.	Drug: Lifitegrast 5% Ophthalmic Solution; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in corneal higher order aberrations	Change in corneal higher order aberrations after 7, 14, and 28 days of treatment.	After 7, 14, and 28 days of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in OSI after 7, 14, and 28 days of treatment.	Change in OSI after 7, 14, and 28 days of treatment.	After 7, 14, and 28 days of treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best corrected visual acuity after 7, 14, and 28 days of treatment.	Change in best corrected visual acuity after 7, 14, and 28 days of treatment.	After 7, 14, and 28 days of treatment.

Collaborators and Investigators

• Sponsor: Research Insight LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): October 8, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: CLIF606A1US08T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor, and such that confidential or proprietary information is not disclosed,

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No