Kera Sol Eye Drops for Dry Eye

Overseen By Tiffany Facile

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vance Thompson Vision

Must not be taking: Topical dry eye

Disqualifiers: Corneal pathology, Ocular inflammation, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Kera Sol eye drops to determine their effectiveness in reducing eye discomfort after LASIK surgery. Researchers aim to understand how these drops affect symptoms like dryness and irritation in the first two weeks post-surgery. Participants will either use Kera Sol drops or follow the usual care without them. This trial is for individuals scheduled for LASIK in both eyes and not currently using other dry eye medications. As a Phase 4 trial, Kera Sol is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

You will need to stop using any topical prescription dry eye medications like lifitegrast or cyclosporine to participate in this trial.

What is the safety track record for Kera Sol Eye Drops?

Research has shown that Kera Sol Eye Drops are generally safe. Kera Sol is an over-the-counter artificial tear solution designed to quickly relieve dry eyes without harming the eye's surface.

Past studies have demonstrated that Kera Sol is well-tolerated by users, providing short-term relief from the burning sensation often linked to dry eyes. No major safety issues have been reported with its use. Since this trial is in a later phase, the treatment has already undergone safety testing in humans, making serious side effects unlikely.

Overall, Kera Sol appears to be a safe choice for those experiencing temporary discomfort after LASIK surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Kera Sol Eye Drops are unique because they might offer faster relief for dry eye symptoms compared to existing treatments, which often include artificial tears, anti-inflammatory drops, or prescription medications like cyclosporine. Researchers are excited about Kera Sol because it is administered four times a day for just 14 days, showing potential for quicker effectiveness. Unlike most treatments that can take weeks to work, Kera Sol could provide noticeable results in a much shorter timeframe, making it a potentially game-changing option for those suffering from dry eyes.

What is the effectiveness track record for Kera Sol Eye Drops in treating dry eye after LASIK?

In this trial, participants will be randomized to receive either Kera Sol Eye Drops or no intervention. A previous study showed that Kera Sol Eye Drops can reduce symptoms of dry eye. The drops calm the immune response in the eyes, preventing damage and supporting the production of a healthy tear layer. Research indicates that these drops can reduce irritation and improve overall eye comfort. Patients with varying levels of dry eye severity have benefited from similar treatments, with many experiencing fewer symptoms. Overall, Kera Sol has proven effective in improving eye moisture and comfort for those dealing with dry eye issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Dan Terveen, MD

Principal Investigator

Vance Thompson Vision Clinic Prof. LLC

Are You a Good Fit for This Trial?

This trial is for individuals at least 18 years old who are undergoing LASIK eye surgery and can sign a consent form. Participants must be able to read, fill out questionnaires, use Kera Sol Eye Drops as directed, and attend all study visits.

Inclusion Criteria

I am willing and able to sign the consent form.

I can read and fill out questionnaires by myself.

I have given my verbal and written consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Kera Sol tears dosed QID for 14 days following LASIK surgery

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kera Sol Eye Drops

Trial Overview The study tests the effectiveness of Kera Sol Eye Drops on dry eye symptoms caused by STODS in patients after their LASIK surgery. It monitors changes during the first two weeks post-operation.

How Is the Trial Designed?

Group I: Kera Sol Active Control 1 Intervention

Subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.

Group II: Standard of Care Active Control 1 Intervention

No Kera Sol drops

Who Is Running the Clinical Trial?

Vance Thompson Vision

Lead Sponsor

Trials

11

Recruited

300+

Citations

1. surfaceophthalmics.com surfaceophthalmics.com/pipeline/

Pipeline This topical immunomodulatory effect is expected to both reduce immune-mediated damage to the lacrimal glands as well as stimulate tear film mucin production - ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05825586?cond=%22Conjunctival%20Disease%22&intr=%22Pharmaceutical%20Solutions%22&viewType=Table&rank=9

PMCF Study to Evaluate Performance and Safety of ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2709003/

Treatment of patients with keratoconjunctivitis sicca with ... Results: The severity of KCS was mild in 18.6%, moderate in 59.9%, and severe in 21.5% of patients based on physicians' assessment.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01797822

Effects of Dry Eye Treatments on the Ocular Surface This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0054254

Dry Eyes (DBCOND0054254) ... Dry Eye Symptoms Using Stem Cells Fortified Eye Drops, No drug interventions, treatment, 4, recruiting. NCT07155070. Efficacy of Kera Sol Tears on Signs and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9253213/

Selective Pharmacologic Therapies for Dry Eye Disease ... Selective Pharmacologic Therapies for Dry Eye Disease Treatment: Efficacy, Tolerability, and Safety Data Review from Preclinical Studies and ...

7. college-optometrists.org college-optometrists.org/clinical-guidance/clinical-management-guidelines/dryeye_keratoconjunctivitissicca_kcs

Dry eye (keratoconjunctivitis sicca, KCS) Click here to read the latest clinical management guidelines for dry eye. Discover causes, symptoms & treatments plus the latest optometry evidence.

8. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye

FDA warns consumers not to purchase or use certain eye ... FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections.