Dry Eye
Conditions
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)
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.
Interventions
DRUGKera Sol Eye Drops
Eye drops
Sponsors
Vance Thompson Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline of Corneal Staining | 14 days | 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. |
Countries
United States
Contacts
CONTACTTiffany Facile
PRINCIPAL_INVESTIGATORDan Terveen, MD
Vance Thompson Vision Clinic Prof. LLC
Outcome results
None listed