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

ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVance Thompson Vision

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Kera Sol Eye Drops

    Drug

    Eye drops

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Kera SolActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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