Status:
RECRUITING
Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
Lead Sponsor:
Vance Thompson Vision
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ocul...
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 prescri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07155070
Start Date
August 1 2025
End Date
February 1 2026
Last Update
September 11 2025
Active Locations (1)
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1
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States, 57108