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

NCT04669561 | Completed Phase 4 FDA Drug

• 1 other identifier: CLIF606A1US08T
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in OSI after 7, 14, and 28 days of treatment.

  After 7, 14, and 28 days of treatment.

Other Outcomes (1)

• Change in best corrected visual acuity after 7, 14, and 28 days of treatment.

  After 7, 14, and 28 days of treatment.

Study Arms (1)

Single /arm

EXPERIMENTAL

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

Interventions

Lifitegrast 5% Ophthalmic Solution DRUG

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.

Single /arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (3)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• John Hovanesian, MD

  Research Insight LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, prospective, open label, self-controlled, single group study

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: March 17, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 8, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)