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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kera Sol | Active Comparator | Subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days. |
|
| Standard of Care | No Intervention | No Kera Sol drops |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kera Sol Eye Drops | Drug | Eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Facile | Contact | 605-371-7075 | tiffany.facile@vancethompsonvision.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Terveen, MD | Vance Thompson Vision Clinic Prof. LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision Clinic, Prof. LLC | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2025 | Sep 4, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2025 | Sep 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
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