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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye

NCT06537349

Dry Eye

NOT_YET_RECRUITING NA

Safety and Efficacy of TOP1630 for Dry Eye Syndrome

NCT03088605

Dry Eye Syndrome

COMPLETED PHASE2

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

NCT00611403

Dry Eye Syndromes

COMPLETED PHASE2

Study of TOP1630 for Dry Eye Syndrome

NCT03833388

Dry Eye Syndrome

COMPLETED PHASE2/PHASE3

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT00404131

Dry Eye Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective, single-site, two-arm randomized study evaluating the impact of, Kera Sol tears on the signs and symptoms of STODS in 60 patients who underwent bilateral LASIK. Both groups will be prescribed the standard of care post-operative prescription combination steroid and antibiotic drop. Additionally, subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm randomized study evaluating the impact of, Kera Sol tears on the signs and symptoms of STODS in 60 patients who underwent bilateral LASIK. Both groups will be prescribed the standard of care post-operative prescription combination steroid and antibiotic drop.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kera Sol

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

Group Type ACTIVE_COMPARATOR

Kera Sol Eye Drops

Intervention Type DRUG

Eye drops

Standard of Care

No Kera Sol drops

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kera Sol Eye Drops

Eye drops

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes