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

NCT07155070 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Surface IIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Baseline of Corneal Staining

  Using the National Eye Institute (NEI) scale system. The NEI scale system for grading fluorescein staining divides the corneal and conjunctival surfaces. The conjunctival surface is divided into 6 areas and the corneal surface is divided into 5 areas. A standardized grading system of 0 to 3 is used for each of areas on cornea and conjunctiva. The maximum staining score for the cornea is 15, and for conjunctiva, the maximum score is 18. The values above 3 is considered abnormal for cornea or conjunctiva in each eye. Grade 0 (i.e., no staining) indicates normal cornea or normal conjunctiva Grade 3 (i.e., highest severity staining) indicates severe ocular surface damage NEI Scale ranges from 0-4. Grade 0 = no dots; Grade 1 = 1-15 dots; Grade 2 = 16-30 dots, and Grade 3 = 31 or \> dots.

  14 days

Study Arms (2)

Kera Sol

ACTIVE COMPARATOR

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

Drug: Kera Sol Eye Drops

Standard of Care

NO INTERVENTION

No Kera Sol drops

Interventions

Kera Sol Eye Drops DRUG

Eye drops

Kera Sol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, 57108, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Dan Terveen, MD

  Vance Thompson Vision Clinic Prof. LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Facile

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: August 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)