Recruiting

Kera Sol

Sponsor:

Vance Thompson Vision

Code:

NCT07155070

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Kera Sol Eye Drops

Study Details

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)

Conditions

Dry Eye

Study ID

NCT07155070

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Kera Sol

Subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.

no intervention: Standard of Care

No Kera Sol drops

Interventions

Kera Sol Eye Drops

Eye drops

Primary outcome measure

  • Change in Baseline of Corneal Staining [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Tiffany Facile

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

Locations

Vance Thompson Vision Clinic, Prof. LLC

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Tiffany Facile

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

More Information

Sponsor

Vance Thompson Vision

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vance Thompson Vision on 2026-07-13.