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

• Status: Completed
• Trial end date: 2021-10-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Research Insight LLC
• Treatments: Lifitegrast; Ophthalmic Solutions

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.