NCT07155070 Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
| NCT ID | NCT07155070 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Vance Thompson Vision |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Dan Terveen, MD
PRINCIPAL INVESTIGATOR
Vance Thompson Vision Clinic Prof. LLC
Frequently Asked Questions
Who can join the NCT07155070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07155070 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07155070 currently recruiting?
Yes, NCT07155070 is actively recruiting participants. Contact the research team at tiffany.facile@vancethompsonvision.com for enrollment information.
Where is the NCT07155070 trial being conducted?
This trial is being conducted at Sioux Falls, United States.
Who is sponsoring the NCT07155070 clinical trial?
NCT07155070 is sponsored by Vance Thompson Vision. The principal investigator is Dan Terveen, MD at Vance Thompson Vision Clinic Prof. LLC. The trial plans to enroll 60 participants.