About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Kera Sol Eye Drops
DrugEye drops
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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