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

 
 
 
 
 
Assessing the Clinical Performance of Two Frequent 
Replacement Silicone Hydrogel Multifocal Contact Lenses 
 
STUDY ID 
CLN705‐M102 
 
 
PROTOCOL 
 
 
NCT05702541 
 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 1 of 21 
 
Alcon – Business Use Only 
 
Feasibility Clinical 
Protocol for CLN705-M102 
Title: Assessing the Clinical Performance of Two Frequent Replacement 
Silicone Hydrogel Multifocal Contact Lenses 
 
Protocol Number 
and Version: 
CLN705-M102, Version 4.0 
Sponsor Name and 
Address: 
Alcon Research, LLC and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Test Product(s): 
 LID223194 MF SiHy Contact lenses  
 
Sponsor Contact Details 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of 
Alcon 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 2 of 21 
 
Alcon – Business Use Only 
Investigator Agreement: 
• I have read the Feasibility Clinical 
Protocol described herein and the 
Feasibility Clinical Master 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-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 3 of 21 
 
Alcon – Business Use Only 
Table of Contents 
Feasibility Clinical 
Protocol for CLN705-M102 ............................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 3 
Abbreviations and Acronyms ..................................................................................................... 4 
1 
FEASIBILITY CLINICAL 
PROTOCOL................................................................... 5 
 
 
1.2 
Study Overview ................................................................................................... 7 
1.3 
Study Product and Associated Materials ........................................................... 13 
1.4 
Study-Specific Lens Returns ............................................................................. 19 
1.4.1 
Worn IP ..............................................................................................19 
1.4.2 
Lens Return (ADE/Device Deficiency) .............................................19 
 
 
 
 
 
 
 
 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................. 16 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 4 of 21 
 
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 
 
 
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 
 
 
 
 
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 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 5 of 21 
 
Alcon – Business Use Only 
Abbreviation 
Definition 
VA 
Visual acuity 
 
1 FEASIBILITY CLINICAL 
PROTOCOL 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 6 of 21 
 
Alcon – Business Use Only 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 7 of 21 
 
Alcon – Business Use Only 
1.2 Study Overview 
Protocol Study Details 
Study Rationale 
and Objective 
In this clinical trial, clinical performance of LID#223194 Multifocal 
contact lens and a commercially available Air Optix plus 
HydraGlyde Multifocal contact lens will be assessed. 
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 (LID223194): 2 days (+ 3 days) 
 Comparator Product (AirOptix HydraGlyde MF [AOHG MF]): 2 
days (+3 days) 
Exposure of study lenses in 2 different periods over 3 visits 
Number of Subjects Planned to enroll: ~35 
Target to complete: 25 - 30 
Study Population 
• Habitual soft Multifocal contact lens wearers aged ≥ 40 years 
with normal eyes (not needing ocular medication, other than 
correction for refractive error). Subjects should have at least 3 
months wearing experience, wear these lenses at least 5 days per 
week and at least 8 hours per day. 
• To qualify, subjects must require cylindrical correction ≤ 0.75D, 
be able wear study contact lens with sphere power ranging 
between +3.00D and -7.00D  and requiring a near ADD of LO, 
MED or HI 
Lens Assignment 
Subjects will be randomized in a 1:1 manner to receive one of 2 lens 
sequences:  
• Sequence 1: LID223194/AOHG MF 
• Sequence 2: AOHG MF/LID223194 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 8 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
Study Design 
 Prospective 
 Single-masked (trial subject) 
 Open-label 
 Randomized 
 Single group 
 Parallel group 
 Crossover 
 Other 
 Contralateral 
 Bilateral 
 Monocular lens wear 
Visit Schedule: 
1. Visit 1 - Screening/Baseline/Dispense Lens 1  
2. Visit 2 (2 (+3) days after Visit 1) Follow-up (to occur at least 
4-6 hours after lens insertion) Lens Pair 1/Dispense Lens 2 
3. Visit 3 (2(+3) days after Visit 2) Follow-up (to occur at least 
4-6 hours after lens insertion) /Exit 
Decision Criteria 
Not applicable 
Assessments 
1. VA with study lenses (logMAR; OU) @ 4m   
Safety Assessments 
1. AEs 
2. Biomicroscopy 
3. Device deficiencies  

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 9 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
Inclusion Criteria 
1. Subject must be at least 40 years of age.  
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. Subject must be willing to stop wearing their habitual contact 
lenses for the duration of study participation. 
4. Currently wears multifocal soft contact lenses in both eyes for a 
minimum of 5 days per week and 8 hours per day during the 
past 3 months. 
5. Manifest cylinder ≤ 0.75 D in each eye. 
6. BCVA 0.1 logMAR or better in each eye. 
7. Able to fit with available contact lenses : within a range of 
powers from +3.00D to -7.00 and requiring a near ADD of LO, 
MED or HI 
8. 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. 
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 
 in the study.  

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 10 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
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 
Statistical Analysis 
 
 
The following product or lens naming conventions will be used:  
• LID223194 
• AOHG MF 
 
Subject 
Characteristics 
and Study 
Conduct 
Summaries 
The following will be presented: 
• Demographics Characteristics (listing) 
Assessment 
Analysis Strategy 
. 
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. 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 11 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
VA with study 
lenses 
Visual Acuity 
 
 
• 4m (OU) 
Table for 
continuous 
variables 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 12 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
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-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 13 of 21 
 
Alcon – Business Use Only 
1.3 Study Product and Associated Materials 
 
Test Product  
LID223194 
 
Comparator Product 
AIR OPTIX plus HydraGlyde Multifocal 
Primary 
component/ 
material 
Lehfilcon A 
Lotrafilcon B 
Manufactu
rer 
Alcon Laboratories, Inc.  
Alcon Laboratories, Inc. 
Power 
Range 
• LO Add with +1.00 to -5.00D (in 0.25D steps) 
spherical power as available 
•  MED Add with +3.00D to -7.00D  (in 0.25D 
steps) spherical power as available  
• HI Add with +3.00D to -7.00D  (in 0.25D steps) 
spherical power as available 
• LO Add with +1.00 to -5.00D (in 0.25D steps) 
spherical power as available 
•  MED Add with +3.00D to -7.00D (in 0.25D 
steps) spherical power as available  
• HI Add with +3.00D to -7.00D (in 0.25D steps) 
spherical power as available 
Supply 
The sponsor will provide this test product. 
The site will procure this comparator product 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 14 of 21 
 
Alcon – Business Use Only 
 
Test Product  
LID223194 
 
Comparator Product 
AIR OPTIX plus HydraGlyde Multifocal 
Packaging 
and 
Labeling  
Primary label on blister foil pack includes, at a 
minimum: 
• 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 includes: 
• clinical protocol number 
• material name or identifier 
• power 
• an investigational use only statement 
• tracking or handling unit number 
Commercial primary label on blister foil pack 
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.  
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.  

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 15 of 21 
 
Alcon – Business Use Only 
 
Test Product  
LID223194 
 
Comparator Product 
AIR OPTIX plus HydraGlyde Multifocal 
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. 
• 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-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 16 of 21 
 
Alcon – Business Use Only 
Table 1-1 
Schedule of Study Procedures and Assessments 
 
Procedure/ Assessment 
Visit 1  
 
 
Visit 2 
Visit 3 
Unscheduled 
Visit/Early Exit 
Visit 
Source 
Only* 
Screening/
Baseline/ 
Dispense 
Lens 1 
Follow up Lens 1 
(2 (+ 3) Days) 
after Visit 1 
(minimum 4 - 
6 hrs after 
insertion) 
Dispense 
Lens 2 
Follow up Lens 2 
(2(+3) Days) after 
Visit 2 (minimum 4-
6 hrs after 
insertion)/Exit 
 
 
1 
Informed Consent 
X 
 
 
 
 
 
2 
Demographics 
X 
 
 
 
 
 
3 
Medical History 
X 
X 
X 
X 
X 
X 
4 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
5 
Inclusion/ Exclusion 
X 
 
 
 
 
 
6 
Habitual lens 
(brand, power) 
X 
 
 
 
 
X 
7 
VA w/ habitual correction 
(OD, OS, Snellen distance) 
X 
(X) 
(X) 
(X) 
(X) 
X 
8 
Manifest refraction (most plus 
spherical equivalent) 
X 
 
 
 
 
(X) 
 
9 
BCVA 
(OD, OS, logMAR; distance and 
near with manifest refraction) 
X 
 
 
 
(X) 
 
10 
Biomicroscopy 
X 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 17 of 21 
 
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13 
Randomize 
X 
 
 
 
 
 
14 
Dispense study lenses 
X 
 
X 
 
(X) 
 
18 
VA w/ study lenses,  
(logMAR) 
• 
Distance (4m; OU) 
X 
X 
X 
X 
(X) 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 18 of 21 
 
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27 
AEs  
X 
X 
X 
X 
X 
 
28 
Device deficiencies  
X 
X 
X 
X 
X 
 
29 
Exit Form 
(X) 
(X) 
(X) 
X 
(X) 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 19 of 21 
 
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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 
Notify via email the CSS and Clinical Trial & Operations Lead when lenses are returned. 
 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 20 of 21 
 
Alcon – Business Use Only 

Document ID: 
V-CLN-0035558 
Status: Approved, Version: 4.0 
Approved Date: 11 Jan 2023 
Page 21 of 21 
 
Alcon – Business Use Only