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Recruiting Phase 4 NCT07155070

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

Trial Parameters

Condition Dry Eye
Sponsor Vance Thompson Vision
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-01
Completion 2025-12-30
Interventions
Kera Sol Eye Drops

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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 pa

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