BridgeMD
Tests treatment safety and results for Dry Eye
Official title Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
ClinicalTrials.gov ID: NCT07155070
What this study is testing
What is Kera Sol Eye Drops?
Kera Sol Eye Drops is an investigational medicine, being studied as a potential treatment for dry eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Autoimmune or immunodeficiency diseases
- Pregnant or nursing women
- Patients with history of previous ocular surgery, , except for previous cataract surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Sioux Falls, South Dakota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sioux Falls, South Dakota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.