Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
Recruiting now · Phase 4
Conditions studied: Dry Eye
In brief
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)
Key facts
- Study ID
- NCT07155070
- Run by
- Vance Thompson Vision
- People needed
- 60
- Starts
- 2025-08-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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, , except for previous cataract surgery.
Where it is running
- Vance Thompson Vision Clinic, Prof. LLC — Sioux Falls, South Dakota, United States (enrolling)
Full record on ClinicalTrials.gov
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