Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
Purpose
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)
Condition
- Dry Eye
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
More Details
- Status
- Recruiting
- Sponsor
- Vance Thompson Vision
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.