Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
Phase: NA
Conditions: Refractive Ametropia
Sponsor: Alcon Research

 
 
 
 
 
Clinical Evaluation of a Manufacturing Process for a 
Frequent Replacement Silicone Hydrogel Multifocal 
Contact Lens 
 
 
STUDY ID 
CLN705-M103 
 
PROTOCOL 
 
 
NCT05765227 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 1 of 21 
 
Alcon – Business Use Only 
 
Feasibility Clinical 
Protocol for CLN705-M103 
Title: Clinical evaluation of a manufacturing process for a frequent 
replacement silicone hydrogel multifocal contact lens 
 
Protocol Number 
and Version: 
CLN705-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): 
Lehfilcon A Multifocal SiHy contact lens  
 
Air Optix plus Hydraglyde MF contact lens (AOHG MF) 
 
 
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-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 2 of 21 
 
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-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 3 of 21 
 
Alcon – Business Use Only 
Table of Contents 
Feasibility Clinical 
Protocol for CLN705-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 ............................................................................. 19 
1.4.1 
Worn IP ..............................................................................................19 
 
 
 
 
 
 
 
 
 
 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................. 15 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 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-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 5 of 21 
 
Alcon – Business Use Only 
Abbreviation 
Definition 
VA 
Visual acuity 
 
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 evaluate the clinical 
performance of a manufacturing process on a frequent replacement 
multifocal contact lens 
Investigator(s) 
Site 
Johns Creek Research Clinic 
11460 Johns Creek Parkway 
Johns Creek, GA, 30097 USA 
External 
Organizations 
Not Applicable 
Planned Duration 
of Exposure  
Subjects will be exposed to up to 2 study lenses per eye, each will 
be worn for 2 days (+3 days):  
•  Study Lens 1 
Number of Subjects Planned to enroll: Up to 150 
subjects 
 
 
 
Target to complete: Up to 150 
subjects 
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 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 6 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
between +3.00D and -7.00D  and requiring a near ADD of LO, 
MED or HI 
Lens Assignment 
No formal randomization will be implemented (a predetermined 
order will be provided by Sponsor, if applicable). 
Study Design 
 Prospective 
 Single-masked (trial subject) 
 Open-label 
 Randomized 
 Single group 
 Parallel group 
 Crossover 
 Other: either single group or 
crossover depending on number 
of study lenses evaluated 
 Contralateral 
 Bilateral 
 Monocular lens wear 
Visit Schedule: 
• If only 1 study lens to be tested in a trial: 
1. Visit 1 - Screening/Baseline/Dispense Lens 1  
2. Visit 2 (2 (+3) days after Visit 1) Follow-up Lens 1 (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; OU) @ 4m   
 
 
  

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 7 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
Safety Assessments 
1. AEs 
2. Biomicroscopy 
3. Device deficiencies  
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. 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 8 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
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, as available 
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.  
11. Participation of the subject in a clinical trial within the previous 
2 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 
 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 9 of 21 
 
Alcon – Business Use Only 
Protocol Study Details 
The following product or lens naming conventions will be used:  
 
 
 
 
 
 
• AOHG MF 
 
 
Subject 
Characteristics 
and Study 
Conduct 
Summaries 
The following will be presented: 
• Conduct 
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. 
Planned 
Effectiveness 
Analyses 
 
   
Title 
Assessment  
Analysis 
VA with study 
lenses 
Visual Acuity 
 
 
• 4m (OU) 
 
 
 
 
Table for 
continuous 
variables 
(Dispense, 
Follow-up) 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 10 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-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 11 of 21 
 
Alcon – Business Use Only 
1.3 Study Product and Associated Materials 
 
Test Product 1 
[
 MF contact 
lenses or LID] 
Comparator Product 1 
[AIR OPTIX plus 
HydraGlyde Multifocal] 
Primary 
component/ 
material 
Lehfilcon A 
Lotrafilcon B 
Manufacturer 
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. 
Packaging and 
Labeling  
Primary label on blister 
foil pack includes, at a 
minimum: 
• material name or 
identifier  
• base curve 
Commercial primary and 
secondary labeling and 
packaging 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 12 of 21 
 
Alcon – Business Use Only 
 
Test Product 1 
[
 MF contact 
lenses or LID] 
Comparator Product 1 
[AIR OPTIX plus 
HydraGlyde Multifocal] 
• 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 
[If product is marketed 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 13 of 21 
 
Alcon – Business Use Only 
 
Test Product 1 
[
MF contact 
lenses or LID] 
Comparator Product 1 
[AIR OPTIX plus 
HydraGlyde Multifocal] 
include the following] 
Commercial primary 
label on blister foil pack 
includes:  
• material name  
• base curve 
• diameter 
• packing solution 
• power 
• lot number 
• expiration date 
• content statement 
• country of origin 
• manufacturer 
information 
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.  
Associated 
• CLEAR CARE Cleaning and Disinfecting Solution will be used with study 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 14 of 21 
 
Alcon – Business Use Only 
 
Test Product 1 
[
 MF contact 
lenses or LID] 
Comparator Product 1 
[AIR OPTIX plus 
HydraGlyde Multifocal] 
 
 
 
Materials 
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-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 15 of 21 
 
Alcon – Business Use Only 
Table 1-1 
Schedule of Study Procedures and Assessments 
 
Procedure/ Assessment 
Visit 1 
Visit 2 
 
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) 
Exit 
1 
Informed Consent 
X 
 
 
 
 
2 
Demographics 
X 
 
 
 
 
3 
Medical History 
X 
X 
 
X 
X 
4 
Concomitant Medications 
X 
X 
 
X 
X 
5 
Inclusion/ Exclusion 
X 
 
 
 
 
6 
Habitual lens 
(brand, power) 
X 
 
 
 
 
7 
VA w/ habitual correction 
(OD, OS, Snellen distance) 
X 
(X) 
X 
(X) 
X 
8 
Manifest refraction (most plus sphero-
cylindrical) 
(data for repeat subjects – ILB in EDC) 
X 
 
 
(X) 
(X) 
 
9 
BCVA 
(OD, OS, logMAR; distance and near 
with manifest refraction) 
X 
 
(X) 
(X) 
 
10 Biomicroscopy 
X 
X 
 
X 
 
 
 
 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 16 of 21 
 
Alcon – Business Use Only 
 
Procedure/ Assessment 
Visit 1 
Visit 2 
 
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) 
Exit 
 
 
 
 
13 Dispense study lenses 
X 
 
 
(X) 
X 
17 VA w/ study lenses,  
(logMAR) 
• Distance (4m; OU) 
 
 
 
 
 
 
X 
X 
 
(X) 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 17 of 21 
 
Alcon – Business Use Only 
 
Procedure/ Assessment 
Visit 1 
Visit 2 
 
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) 
Exit 
27 Collect worn lenses 
 
X 
 
(X) 
 
28 AEs  
X 
X 
X 
X 
 
29 Device deficiencies  
X 
X 
X 
X 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 18 of 21 
 
Alcon – Business Use Only 
 
Procedure/ Assessment 
Visit 1 
Visit 2 
 
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) 
Exit 
30 Exit Form 
(X) 
(X) 
X 
(X) 
 
 
 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 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. 
If worn IP is to be returned, provide all of the following specifications: 
• 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 Lot number 
o Date collected 
• Storage solution: PURILENS Plus Preservative Free Saline (PURILENS Plus Saline) 
• Storage temperature: Refrigerated 4-10°C 
• Timing of return: Study Completion or periodically as communicated by sponsor 
• An inventory/list of lenses being returned 
 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 20 of 21 
 
Alcon – Business Use Only 

Document ID: 
V-CLN-0038373 
Status: Approved, Version: 1.0 
Approved Date: 22 Feb 2023 
Page 21 of 21 
 
Alcon – Business Use Only