ClinicalTrials.gg
RecruitingNCT07155070Updated Jul 13, 2026

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

A Phase 4 interventional study of Kera Sol Eye Drops in Dry Eye, sponsored by Vance Thompson Vision. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Vance Thompson Vision · Phase 4, Interventional, and Other

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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 prescribed the standard of care post-operative prescription combination steroid and antibiotic drop. Additionally, subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.

02

Conditions studied

  • Dry Eye

Browse trials for

03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be willing and able to sign the 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

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 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 for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
  • or immunodeficiency diseases
  • Pregnant or nursing women
  • Patients with history of previous ocular surgery, , except for previous cataract surgery.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Kera Sol

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

    Drug: Kera Sol Eye Drops

  • No intervention
    Standard of Care

    No Kera Sol drops

Interventions

  • DrugKera Sol Eye Drops

    Eye drops

06

What researchers measure

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.

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07155070
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Aug 1, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Tiffany Facile
Contact
tiffany.facile@vancethompsonvision.com
605-371-7075
Dan Terveen, MD
principal investigator · Vance Thompson Vision Clinic Prof. LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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