RECRUITINGPhase 4INTERVENTIONAL
Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
Kera Sol Post-LASIK: A Benefit Study
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- Be willing and able to sign the willing to sign a consent form 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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 weakened immune system diseases
- Pregnant or nursing women
- Patients with history of previous ocular surgery
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Kera Sol Eye Drops
Eye drops
Locations (1)
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States