RecruitingPhase 4NCT07155070

Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK

Kera Sol Post-LASIK: A Benefit Study

Sponsor

Vance Thompson Vision

Enrollment

60 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Dry Eye

Summary

Collecting data using Kera Sol tear usage during the initial two-week post-operative period after Laser-Assisted In Situ Keratomileusis (LASIK) has on the signs and symptoms of surgical temporary ocular discomfort syndrome (STODS)

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Be willing and able to sign the informed consent form (ICF)
Be at least 18 years of age at the screening visit
Be undergoing LASIK treatment in both eyes
Be literate and able to complete questionnaires independently
Be able and willing to use the study drug and participate in all study assessments and visits
Have provided verbal and written informed consent

Exclusion Criteria11

Use of topical prescription dry eye medications such as lifitegrast, cyclosporine, loltilaner, etc.
Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect, or corneal ulcer.
Have presence of corneal pathology that may interfere with LASIK outcomes
Active infectious, ocular or systemic disease
Have a history of ocular inflammation or macular edema
Have had clinically significant active infectious keratitis in the past 3 months 7. -Have history of prior refractive surgery
Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
Autoimmune or immunodeficiency diseases
Pregnant or nursing women
Patients with history of previous ocular surgery