Kera Sol eye drops for temporary dry eye after LASIK

Kera Sol Post-LASIK: A Benefit Study

This study will test whether using Kera Sol eye drops four times a day for two weeks helps adults who experience temporary dry eye after LASIK.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vance Thompson Vision (Academic / other)
• Locations: 1 site (Sioux Falls, South Dakota)
• Trial ID: NCT07155070 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-site, randomized, two-arm Phase 4 study enrolling 60 adults who underwent bilateral LASIK. All participants will receive the standard postoperative steroid and antibiotic drops, and half will be randomized to add Kera Sol eye drops dosed four times daily for 14 days while the other half receive standard care alone. Signs and symptoms of surgical temporary ocular discomfort syndrome (STODS) will be tracked during the initial two-week postoperative period using clinical exams and patient questionnaires. The study will compare symptom scores and clinical signs between groups to see if Kera Sol improves early recovery.

Who should consider this trial

Good fit: Adults aged 18 and older undergoing bilateral LASIK who can read and complete questionnaires and are willing to use the study drops and attend follow-up visits.

Not a fit: Patients already using prescription topical dry-eye medications, with corneal epithelial defects, prior refractive surgery, active ocular infection, or other significant ocular pathology are unlikely to benefit and are excluded from this study.

Why it matters

Potential benefit: If successful, Kera Sol could reduce discomfort and clinical signs of temporary post-LASIK dry eye and speed early visual recovery.

How similar studies have performed: Using lubricating eye drops after LASIK is a common practice and has shown symptom relief in prior reports, but published data specific to Kera Sol are limited.

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

Where this trial is running

Sioux Falls, South Dakota

• Vance Thompson Vision Clinic, Prof. LLC — Sioux Falls, South Dakota, United States (Recruiting)

Study contacts

• Principal investigator: Dan Terveen, MD — Vance Thompson Vision Clinic Prof. LLC
• Study coordinator: Tiffany Facile

Conditions Dry Eye