Kera Sol Post-LASIK: A Benefit Study
Phase: PHASE4
Conditions: Dry Eye
Sponsor: Vance Thompson Vision

Kera Sol Post-LASIK: A Benefit Study 
Clinical Study Protocol 
 
A single center randomized controlled, two arm investigator initiated study to assess 
the efficacy of Kera Sol Tears on surgical temporary ocular discomfort syndrome 
(STODS) in subjects following LASIK.  
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Date of Issue:  ​
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04/10/2025 
 
Sponsor:     ​
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Vance Thompson Vision 
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Sponsor Location:  ​
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Vance Thompson Vision ​
 
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3101 West 57th Street 
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Sioux Falls, SD, 57108 
 
Study Name:​ ​
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Kera Sol Post-LASIK: A Benefit Study 
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Study Phase:​ ​
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Investigator-Initiated Trial 
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Kera Sol Post-LASIK: A Benefit Study 
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Clinical Study Protocol Synopsis 
 
Title:  A single center randomized controlled, two arm investigator initiated study to assess the  
efficacy of Kera Sol tears on signs and symptoms of surgical temporary ocular discomfort 
syndrome (STODS) in subjects following LASIK.  
 
Principal Investigator: Vance Thompson / Vance Thompson Vision 
 
Sponsor Location:   ​  Vance Thompson Vision 
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 3101 West 57th Street 
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 Sioux Falls, SD, 57108 
 
Study Name:​ Kera Sol Post-LASIK: A Benefit Study 
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Objective: To evaluate the influence of Kera Sol tear usage during the initial two-week 
postoperative period after LASIK has on the signs and symptoms of STODS. 
Background: Laser-Assisted In Situ Keratomileusis (LASIK) is a common and effective refractive 
surgery that reshapes the cornea to correct vision problems. However, a frequent temporary 
side effect post-surgery is dry eye. This occurs because the LASIK procedure can disrupt the 
corneal nerves responsible for signaling tear production and can also affect the goblet cells in 
the conjunctiva that contribute to the tear film's stability. This neurotrophic effect and potential 
disruption of the ocular surface lead to reduced tear production, increased tear evaporation, 
and an unstable tear film. Given the prevalence of post-LASIK dry eye and the established 
benefits of artificial tears in managing this condition, there is an ongoing need to explore 
formulations that may offer enhanced or more targeted relief. Kera Sol tears, presumably a 
specific formulation of artificial tears, may offer unique benefits due to its specific composition.  
Study Design:  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.  
 
The primary endpoints, assessed using descriptive analysis, will be the change from baseline 
corneal staining on the 0-15 NEI scale and the change from baseline discomfort score on the 
UNC DEMS questionnaire to Day 14. Additional endpoints measured will include uncorrected 
visual acuity (UCVA), BEDx score and best-corrected visual acuity (BCVA) at 1 week, and residual 
refractive error at Day 14. 
 
 
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Kera Sol Post-LASIK: A Benefit Study 
Subject Population: 60 subjects, who have scheduled for LASIK in both eyes, will be enrolled.  
 
Materials and Methods 
 
●​ Informed consent will be obtained prior to collection of any data.   
●​ Each subjects’ demographics, medical history, will be reviewed. 
●​ Inclusion and exclusion criteria will be reviewed for each subject.   
●​ Subjects will be asked to report their daily use of study drop 
●​ Subjects will be asked to report their dry eye symptoms using the developed University 
North Carolina Dry Eye Management Scale (UNC DEMS) scale 
●​ Each subjects’ monocular and binocular uncorrected distance visual acuity (UDVA) will 
be obtained on an ETDRS chart at a distance of 20 feet 
●​ A manifest refraction will be performed on each subject. 
●​ Monocular and binocular best corrected distance visual acuity (BCDVA) will be obtained 
on an ETDRS chart at a distance of 20 feet in photopic lighting conditions. 
●​ 25% low contrast sensitivity will be evaluated using a Pelli-Robson chart. 
●​ The subjects’ eyes will be thoroughly examined at the slit lamp. 
●​ Corneal fluorescein staining will be evaluated using the BEDx software 
●​ Intraocular pressure will be obtained using clinical standard of care 
 
 
 
 
 
 
Inclusion criteria:   
 
1.​ Be willing and able to sign the informed consent form (ICF) 
2.​ Be at least 18 years of age at the screening visit 
3.​ Be undergoing LASIK treatment in both eyes 
4.​ Be literate and able to complete questionnaires independently 
5.​ Be able and willing to use the study drug and participate in all study assessments and 
visits 
6.​ Have provided verbal and written informed consent 
 
 General Exclusion criteria:   
 
1.​ Use of topical prescription dry eye medications such as lifitegrast, cyclosporine, 
loltilaner, etc. 
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Kera Sol Post-LASIK: A Benefit Study 
2.​ Have a break in the integrity of the corneal epithelium such as a persistent corneal 
epithelial defect, or corneal ulcer. 
3.​ Have presence of corneal pathology that may interfere with LASIK outcomes 
4.​ Active infectious, ocular or systemic disease 
5.​ Have a history of ocular inflammation or macular edema 
6.​ Have had clinically significant active infectious keratitis in the past 3 months 
7.​ Have history of prior refractive surgery 
8.​ Have placement of temporary punctal plugs in the past 1 month or current presence of 
permanent punctal plugs at time of screening 
9.​ 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) 
10.​ Autoimmune or immunodeficiency diseases 
11.​ Pregnant or nursing women 
12.​ Patients with history of previous ocular surgery 
 
 
 
Procedures 
 
Subjects will be recruited from the site’s current patient population who have been scheduled 
and underwent bilateral LASIK procedure. Enrollment and informed consent will be 
administered by study coordinators. Data will be collected by investigators and study 
coordinators as follows. Data may be carried from standard of care visits within 90 days of Visit 
one. 
 
Visit 1 (pre-op):  
o​ Informed consent will be obtained prior to collection of any data 
o​ Each subjects’ demographics, medical, and concomitant medications will be 
reviewed. 
o​ Inclusion and exclusion criteria will be reviewed for each subject.  
o​ University North Carolina Dry Eye Management Scale (UNC DEMS) questionnaire 
will be administered 
o​ Concomitant medications will be reviewed. 
Visit 2 (1 day post-op):  
o​ Randomization will occur 
o​ Daily topical artificial tear and study drop log will be provided 
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Kera Sol Post-LASIK: A Benefit Study 
o​ University North Carolina Dry Eye Management Scale (UNC DEMS) questionnaire 
will be administered 
o​ Monocular and binocular uncorrected distance visual acuity (UDVA) will be 
obtained on an ETDRS chart at a distance of 20 feet 
o​ 25% low contrast sensitivity will be measured using the Pelli-Robson chart 
o​ Slit lamp examination will be performed 
o​ Corneal fluorescein staining will be obtained using the BEDx software 
o​ Adverse events will be collected 
Visit 3 (7 +/-2 days post-op):  
o​ Daily topical artificial tear and study drop log will be provided 
o​ University North Carolina Dry Eye Management Scale (UNC DEMS) questionnaire 
will be administered 
o​ Monocular and binocular uncorrected distance visual acuity (UDVA) will be 
obtained on an ETDRS chart at a distance of 20 feet 
o​ Manifest refraction will be performed 
o​ Monocular and binocular best corrected distance visual acuity (BCDVA) will be 
obtained on an ETDRS chart at a distance of 20 feet 
o​ 25% low contrast sensitivity will be measured using the Pelli-Robson chart 
o​ Slit lamp examination will be performed 
o​ Corneal fluorescein staining will be obtained using the BEDx software 
o​ Adverse events will be collected 
Visit 4 (14 +/-2 days post-op):  
o​ Daily topical artificial tear and study drop log will be provided 
o​ University North Carolina Dry Eye Management Scale (UNC DEMS) questionnaire 
will be administered 
o​ Monocular and binocular uncorrected distance visual acuity (UDVA) will be 
obtained on an ETDRS chart at a distance of 20 feet 
o​ Manifest refraction will be performed 
o​ Monocular and binocular best corrected distance visual acuity (BCDVA) will be 
obtained on an ETDRS chart at a distance of 20 feet 
o​ 25% low contrast sensitivity will be measured using the Pelli-Robson chart 
o​ Slit lamp examination will be performed 
o​ Corneal fluorescein staining will be obtained using the BEDx software 
o​ Intraocular pressure will be measured per standard of clinical care 
o​ Adverse events will be collected 
 
 
 
 
 
 
 
 
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Kera Sol Post-LASIK: A Benefit Study 
 
 
Data Analysis and Data Monitoring 
 
Data will be captured by the principal investigators, sub-investigators and study coordinators.  
Data will be documented on source documents and subjects will be identified as subject 
numbers. 
 
Data analysis will occur on an excel spreadsheet or in R statistical software with subjects 
identified as a subject number. The Excel spreadsheet or R scripts will be on computer(s) that 
are password protected. 
Baseline demographic and ocular characteristics will be quantified using descriptive statistics. 
Statistical analysis will be completed on all primary and secondary endpoints. 
Data Storage and Confidentiality 
Private information and your medical record will be shared with individuals and organizations 
that conduct or watch over this research, including: 
●​ The research sponsor 
●​ People who work with the research sponsor 
●​ The Institutional Review Board (IRB) that reviewed this research 
We may publish the results of this research. However, we will keep all names and other 
identifying information confidential. 
 
We protect all information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 
 
Sources documents will be placed in a binder and stored in locked cabinets.   
This trial will be conducted in compliance with the protocol, GCP, and applicable regulatory 
requirement(s). 
 
The participation for this trial is voluntary and subjects may stop or withdraw during the 
one-time examination at their discretion.   
 
The principal investigator will report to the IRB any changes in research activity, serious adverse 
events, and completion of the study. 
 
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