Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Phase: NA
Conditions: Refractive Errors, Presbyopia, Astigmatism
Sponsor: Alcon Research

 
 
 
 
 
Clinical Evaluation of a Monthly Replacement Daily Wear 
Silicone Hydrogel Multifocal Toric Contact Lens 
 
 
STUDY ID  
CLR624‐M103 
 
 
PROTOCOL and STATISTICAL ANALYSIS PLAN 
 
 
NCT05886907 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 1 of 17 
 
Alcon – Business Use Only 
 
Feasibility Clinical 
Protocol for CLR624-M103 
Title: Assessing the Clinical Performance of Two Frequent Replacement 
Silicone Hydrogel Multifocal Toric Contact Lenses 
 
Protocol Number 
and Version: 
CLR624-M103, Version 1.0 
Sponsor Name and 
Address: 
Alcon Research, LLC and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Test Product(s): 
MFT SiHy Contact Lenses; LID223188 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of 
Alcon 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 2 of 17 
 
Alcon – Business Use Only 
Investigator Agreement: 
• I have read the Feasibility Clinical 
Protocol described herein and the 
Feasibility Clinical 
Protocol governing it, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical Practice 
(GCP), the ethical principles contained within the Declaration of Helsinki, this 
protocol, all applicable regulatory authority regulations, and conditions of approval 
imposed by the reviewing IRB or regulatory authority. 
• I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or 
other sources provided by the sponsor. 
• I understand the potential risks and side effects of the investigational product(s). 
• I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements of the sponsor and government 
agencies. 
• I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
Have you ever been disqualified as an investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
 
 
Principal investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
Address: 
 
 
 
 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 3 of 17 
 
Alcon – Business Use Only 
Table of Contents 
Feasibility Clinical 
Protocol for CLR624-M103................................................................ 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 3 
Abbreviations and Acronyms ..................................................................................................... 4 
1 
FEASIBILITY CLINICAL 
PROTOCOL................................................................... 5 
1.1 
Revision History .................................................................................................. 5 
1.2 
Study Overview ................................................................................................... 5 
1.3 
Study Product and Associated Materials ........................................................... 11 
1.4 
Study-Specific Lens Returns ............................................................................. 17 
1.4.1 
Worn IP ..............................................................................................17 
1.4.2 
Lens Return (ADE/Device Deficiency) .............................................17 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................. 13 
 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 4 of 17 
 
Alcon – Business Use Only 
Abbreviations and Acronyms 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
BCVA 
Best corrected visual acuity 
°C 
Degrees Celsius 
CDMA  
Clinical Development & Medical Affairs 
CSS 
Clinical Site Specialist 
CT&OL 
Clinical Trial & Operations Lead 
D 
Diopter(s) 
eCRF 
Electronic case report form 
ESP 
Eye Surface Profiler 
GA 
Georgia 
GCP 
Good Clinical Practice 
ICF 
Informed consent form 
ID 
Identification 
IP 
Investigational product 
IRB 
Institutional review board 
JCR 
Johns Creek Research 
LID 
Lens identification number 
logMAR 
Logarithm of the minimum angle of resolution 
 
 
MFT 
Multifocal toric contact lens 
 
 
MR 
Manifest refraction 
 
 
OD 
Right eye 
OS 
Left eye 
OU 
Both eyes 
PI 
Principal investigator 
R&D 
Research & Development 
SADE 
Serious adverse device effect 
SiHy 
Silicone hydrogel 
US or USA 
United States 
VA 
Visual acuity 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 5 of 17 
 
Alcon – Business Use Only 
 
1 FEASIBILITY CLINICAL 
PROTOCOL 
1.1 Revision History 
Version 
Brief Description and Rationale 
1 
Initial Version of this document 
 
1.2 Study Overview 
Protocol Study Details 
Study Rationale 
and Objective 
The purpose of this clinical trial is to assess on-eye performance and 
overall fit of the 
 Multifocal Toric contact lens to aid in 
confirmation of the study lens design. 
Investigator(s) 
Site 
Johns Creek Research Clinic 
11460 Johns Creek Parkway 
Johns Creek, GA, 30097 USA 
External 
Organizations 
Not Applicable 
Planned Duration 
of Exposure  
~4 days total (test and comparator) 
Test Product: LID223188 for 2 (+3) days   
Comparator Product: Ultra MFT for 2 (+3) days   
Number of Subjects Planned to enroll: ~30 
Target to complete: 20 
Study Population 
Volunteer subjects aged 40 or over who are habitual multifocal soft 
contact lens wearers, have at least 3 months of recent contact lens 
wearing experience.
 
 
  
 
 
 
 
Lens Assignment 
Subjects will not be randomized in this study 
Study Design 
 Prospective 
 Single-masked (trial subject) 
 Open-label 
 Randomized 
 Pre-determined order 
• Even subject #: Lens Pair 1 
– LID223188, Lens Pair 2 – 
Ultra MFT 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
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Alcon – Business Use Only 
Protocol Study Details 
• Odd subject #: Lens Pair 1 – 
Ultra MFT, Lens Pair 2 – 
LID223188 
 Single group 
 Parallel group 
 Crossover 
 Other 
 Contralateral 
 Bilateral 
 Monocular lens wear 
Visit Schedule: 
1. Visit 1: Screening/Baseline/Dispense Lens Pair 1 
2. Visit 2 (2 (+3) days after Visit 1): Follow-up Lens Pair 1 (to 
occur at least 4-6 hours after lens insertion)/Dispense Lens Pair 
2 
3. Visit 3 (2 (+3) days after Visit 2): Follow-up Lens Pair 2 (to 
occur at least 4-6 hours after lens insertion)/Exit 
 
 
 
Decision Criteria 
No prospective decision criteria have been defined for this study. 
Assessments 
1. VA with study lenses (logMAR; distance @ 4m: OU,
 
 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 7 of 17 
 
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Protocol Study Details 
Safety Assessments 
1. AEs 
2. Biomicroscopy 
3. Device deficiencies  
Inclusion Criteria 
1. Subject must be at least 40 years of age and require an ADD.  
2. Subject must be able to understand and must sign an informed 
consent form (ICF) that has been approved by an Institutional 
Review Board (IRB). 
3. Currently wears multifocal soft contact lenses in both eyes 
during the past 3 months. 
4. Manifest cylinder power between -0.75 D and -1.00 D  
5. BCVA logMAR 0.1 (Snellen 20/25) or better in each eye. 
6. Subject must be willing to stop wearing habitual lens for the 
study duration and able to fit with available contact lens powers 
(see Section 1.3). 
7. Subject must possess spectacles that provide a corrected visual 
acuity of 20/40 or better OU.  
Exclusion Criteria 
1. Any anterior segment infection, inflammation, or abnormality or 
disease (including systemic) that contraindicates contact lens 
wear, as determined by the investigator. 
2. Any use of systemic or ocular medications for which contact 
lens wear could be contraindicated, as determined by the 
investigator. 
3. History of refractive surgery or plan to have refractive surgery 
during the study or irregular cornea in either eye. 
4. Ocular or intraocular surgery (excluding placement of punctal 
plugs) within the previous 12 months or planned during the 
study. 
5. Biomicroscopy findings at screening that are moderate (Grade 3) 
or higher and/or corneal vascularization that is mild (Grade 2) or 
higher, and/or any infiltrate. 

Document ID: 
V-CLN-0025584
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
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Alcon – Business Use Only 
Protocol Study Details 
6. Current or history of pathologically dry eye in either eye that, in
the opinion of the investigator, would preclude contact lens
wear.
7. Current or history of herpetic keratitis in either eye.
8. Eye injury in either eye within 12 weeks immediately prior to
enrollment for this trial.
9. Current or history of intolerance, hypersensitivity, or allergy to
any component of the study products.
10. The investigator, his/her staff, family members of the
investigator, family members of the investigator’s staff, or
individuals living in the households of the aforementioned
persons may not participate in the study.
11. Participation of the subject in a clinical trial within the previous
3 days or currently enrolled in any clinical trial.
12. Monovision contact lens wearer.
Enrollment 
Stopping Criteria 
Enrollment stopping criteria will not be defined for this study. 
Analysis Plan 
The following product or lens naming conventions will be used: 
•
•
Ultra MFT
Subject 
Characteristics 
and Study 
Conduct 
Summaries 
The following will be presented: 
•
Conduct
•
Demographics
•
Ct.gov AE table
Assessment 
Analysis Strategy 
Several effectiveness assessments are being conducted in this study. 
Results from selected assessment will be summarized using 
descriptive statistics according to its measurement scale. Listings 
will be provided as necessary. 
The Safety Analysis Set will serve as the analysis data set for all 
effectiveness analyses. 
Planned 
Effectiveness 
Analyses 
The following assessments will be summarized with descriptive 
statistics, and listings will be generated when applicable:   

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 9 of 17 
 
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Protocol Study Details 
Title 
Assessment 
Analysis 
VA with study 
lenses 
Visual Acuity 
• 4m (OU, 
 
Listing, table for 
continuous variables 
(Dispense, Follow-
up) 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
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Protocol Study Details 
 
Interim Analysis  
At the discretion of the CDMA Project Lead, interim evaluations 
may be undertaken to provide early insight into product safety 
and/or effectiveness. 
Sample Size and 
Power 
Calculations 
No formal sample size calculation is provided given the descriptive 
and feasibility nature of the study. 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 11 of 17 
 
Alcon – Business Use Only 
1.3 Study Product and Associated Materials 
 
Test Product 1 
/LID223188 
Comparator Product 1 
Ultra MFT 
Primary 
component/ 
material 
Lehfilcon A 
Samfilcon A 
Manufacturer 
Alcon Laboratories, Inc.  
Bausch + Lomb 
Power Range 
Any combination of the following, as available:  
• Sphere: Plano to -4.00D in 1D steps 
• Cyl: -0.75D 
• Axis: 170, 180, 010, 090 
• Add: Lo, Med, Hi 
Any combination of the following, as available: 
• Sphere: Plano to -4.25D in 0.25D steps 
• Cyl: -0.75D 
• Axis: 170, 180, 010, 090 
• Add: Lo, Hi 
Supply 
The sponsor will provide this test product. 
The site will procure this comparator product. 
Packaging and 
Labeling  
Primary label on blister foil pack includes: 
• material name or identifier  
• base curve 
• diameter 
• packing solution 
• power 
• lot number 
• expiration date 
• content statement 
• investigational device statement 
• sponsor information 
• country of origin 
Secondary color-coded label on packages 
Commercial primary label on blister foil pack. 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 12 of 17 
 
Alcon – Business Use Only 
 
Test Product 1 
/LID223188 
Comparator Product 1 
Ultra MFT 
includes: 
• clinical protocol number 
• material name or identifier 
• power 
• an investigational use only statement 
• tracking or handling unit number 
Storage 
Lenses should be stored at room temperature. 
Refer to manufacturer’s instructions. 
Other 
Replacement lenses are allowed only if there is a device deficiency (e.g., torn lens) or if the lens falls on the 
ground and investigator wants to insert a new lens. 
Associated 
Materials 
• CLEAR CARE Cleaning and Disinfecting Solution will be used with study lenses for the duration of 
study.  
• LacriPure rinsing/reinsertion PRN will be used as needed with study lenses. 
• Lubrication/re-wetting drops will not be permitted during study lens wear. 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 15 of 17 
 
Alcon – Business Use Only 
 
Procedure / Assessment 
Visit 1  
Visit 2  
Visit 3 
Unscheduled 
Visit / Early 
Exit Visit 
Source 
Only* 
Screening / Baseline / 
Dispense Pair 1 
Follow-up Pair 1 
(2 [+3] days after 
Visit 1) 
Dispense Pair 2 
Follow up Pair 2  
(2 [+3] days after 
Visit 3) / Exit 

Document ID: 
V-CLN-0025584 
Status: Approved, Version: 1.0 
Approved Date: 24 May 2023 
Page 17 of 17 
 
Alcon – Business Use Only 
1.4 Study-Specific Lens Returns  
1.4.1 
Worn IP 
Worn IP will be returned to the sponsor. Use the following instructions for collection, storage, 
and shipping, unless otherwise instructed by the sponsor. 
• Removal from eye: Clean hands 
• Storage container: Unused screw-top lens case 
• Label information:  
o Protocol number 
o Site number 
o Subject ID 
o Eye 
o Lens type/ identification 
o Date collected 
• Storage solution: PURILENS Plus Preservative Free Saline (PURILENS Plus Saline) 
• Storage temperature: Refrigerated 4-10°C 
• Timing of return: Study Completion 
• An inventory/list of lenses being returned 
1.4.2 
Lens Return (ADE/Device Deficiency) 
The directions for the collection, storage, and return of lenses associated with an AE or 
device deficiency are listed in the 
 Protocol.