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

RECRUITINGPHASE4

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

NCT07155070•Vance Thompson Vision

View on ClinicalTrials.gov

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)

Detailed Description

Prospective, single-site, two-arm randomized study evaluating the impact of, Kera Sol tears on the signs and symptoms of STODS in 60 patients who underwent bilateral LASIK. Both groups will be prescribed the standard of care post-operative prescription combination steroid and antibiotic drop. Additionally, subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 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
+1 more criteria

Locations (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, United States

Key Dates

Start Date

August 1, 2025

Primary Completion Date

December 30, 2025

Completion Date

February 1, 2026

Last Updated

September 11, 2025

Enrollment

ESTIMATED participants

Conditions

Dry Eye

Interventions

Kera Sol Eye Drops

DRUG

Contacts

Tiffany Facile

CONTACT

605-371-7075 tiffany.facile@vancethompsonvision.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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