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

Vance Thompson Vision

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye

Treatments: Drug: Kera Sol Eye Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT07155070

Surface IIT

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Kera Sol

Active Comparator group

Description:

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

Treatment:

Drug: Kera Sol Eye Drops

Standard of Care

No Intervention group

Description:

No Kera Sol drops