Eye-area care, tested with clinical precision.

Final Report

Clinical Evaluation of the Ophthalmologic Safety-in-Use of an Eye Cream

Tested product: EyeCrème.

Sponsor

SeneGence International
19651 Alter
Foothill Ranch, CA 92610

Sponsor Representative

Nikki Chew
Director, Research & Development

Clinical Testing Facility

Essex Testing Clinic, Inc.
799 Bloomfield Avenue
Verona, NJ 07044

Date of Final Report: January 24, 2022.

Footer: 799 Bloomfield Avenue · Verona, NJ 07044 · (973) 857-9541 · Fax (973) 857-9662.

Signature Page

Clinical Evaluation of the Ophthalmologic Safety-in-Use of an Eye Cream

Tested product: EyeCrème.

• Gabriela Argueta, Project Manager and Study Director — signed January 18, 2022.
• Toni F. Miller, PhD, DABT, BCFE, Scientific Director and Principal Investigator — signed January 21, 2022.
• Lynda Ann Youngworth, MD, Board-Certified Ophthalmologist and Medical Investigator — signed January 18, 2022.

Essex Testing Clinic, Inc.

Quality Assurance Statement

The study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in 21 CFR Part 50, Protection of Human Subjects — Informed Consent, and the Standard Operating Procedures of Essex Testing Clinic, Inc.

For this clinical study, informed consent was obtained. An IRB review was not required.

To assure compliance with the study protocol, the Quality Assurance Unit completed an audit of the applicable study records and report. The report is considered a true and accurate reflection of the testing methods and source data.

Sherri L. Sayles, MS, Manager, Quality Assurance — signed January 21, 2022. Essex Testing Clinic, Inc.

Table of Contents

1. 1.0 Objective — page 1
2. 2.0 Sponsor — page 1; 2.1 Sponsor Representative — page 1
3. 3.0 Clinical Investigators — page 1
4. 4.0 Clinical Testing Facility — page 1
5. 5.0 Study Dates — page 1
6. 6.0 Ethics — page 2; 6.1 Ethical Conduct of the Study — page 2; 6.2 Subject Information and Consent — page 2
7. 7.0 Test Materials — page 2
8. 8.0 Test Subjects — page 2
9. 9.0 Test Procedure — page 3
10. 10.0 Results and Discussion — page 4
11. 11.0 Conclusions — page 4

• Table 1 — Subject Demographics
• Table 2 — Visual Acuity Examinations
• Table 3 — Summary of Ophthalmologist’s Evaluations and Subjects’ One-Week Call-In Comments
• Table 4 — Daily Diary Comments
• Appendix A — Informed Consent Form
• Appendix B — Medical History Form
• Appendix C — Study Protocol
• Appendix D — Data Recording Form
• Appendix E — Daily Diary Form

Clinical Evaluation of the Ophthalmologic Safety-in-Use of an Eye Cream

Tested product: EyeCrème.

1.0 Objective

The objective was to evaluate the ophthalmologic safety-in-use of an eye cream after 2 weeks of use by a panel of 30 female volunteers aged 18 to 69 years, approximately 25% of whom were to be contact-lens wearers. Pre- and post-test eye examinations were performed by a Board-Certified Ophthalmologist to support the claims “Ophthalmologist-Tested” and “Safe for Contact Lens Wearers.”

2.0 Sponsor

SeneGence International, 19651 Alter, Foothill Ranch, CA 92610.

2.1 Sponsor Representative: Nikki Chew, Director, Research & Development.

3.0 Clinical Investigators

• Study Director: Gabriela Argueta, Project Manager.
• Study Coordinator: Jackson Hinden.
• Principal Investigator: Toni F. Miller, PhD, DABT, BCFE, Scientific Director.
• Medical Investigator: Lynda Ann Youngworth, MD, Board-Certified Ophthalmologist.

4.0 Clinical Testing Facility

Essex Testing Clinic, Inc., 799 Bloomfield Avenue, Verona, NJ 07044.

5.0 Study Dates

Start: November 22, 2021. Finish: December 6, 2021.

6.0 Ethics

6.1 Ethical Conduct of the Study. The study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations, the Declaration of Helsinki, and/or Essex Testing Clinic Standard Operating Procedures.

6.2 Subject Information and Consent. The study was conducted in compliance with CFR Title 21, Part 50, Informed Consent of Human Subjects. Informed consent was obtained from each subject in the study and documented in writing before participation. A copy was provided to each subject.

7.0 Test Materials

The test article was provided by SeneGence International, received October 21, 2021, and recorded as 35 jars of a beige semi-solid. The public tested-product identity is EyeCrème.

8.0 Test Subjects

Approximately 35 female subjects, between 18 and 69 years of age and in general good health, were to be empanelled to ensure that at least 30 completed the study; approximately 25% were to be contact-lens wearers. All subjects were required to read, understand, and sign a written Informed Consent Form and complete a brief Medical History Form.

9.0 Test Procedure

The use test was conducted in accordance with the appended Study Protocol.

Potential subjects completed a Medical History Form. Those who met the criteria were given an ophthalmologic examination and then empanelled. A Board-Certified Ophthalmologist examined all enrolled subjects before the study and after the 2-week use period. Subjects called the clinic after 7 days and as necessary during the remainder of the study to document any problems.

Examinations included upper and lower eyelids and margins, conjunctivae, visible corneal anomalies, slit-lamp examinations, and a general examination of the periorbital eye area. A trained evaluator performed pre- and post-test visual-acuity examinations. Findings were recorded on individual Data Recording Forms. Each subject’s Medical History Form recorded the type of contact lenses used. Prospective subjects were asked not to wear eye makeup during the qualifying and final examinations.

Subjects received the eye cream for 2 weeks and were instructed not to use other eye creams or introduce new personal-care products around the face or eye area. A Daily Diary recorded application date and time plus comments or observations. Subjects returned the test article at the final visit.

Directions for Use

1. Use twice a day, morning and night.
2. Apply on upper eyelid and under eye.
3. Record uses in diary.

10.0 Results and Discussion

A total of 31 female subjects, ages 19 to 69 years, including 9 contact-lens wearers, enrolled on November 22, 2021. Thirty (30/31) completed the single-blind home-use test on December 6, 2021. Subject No. 14 left the study for personal reasons unrelated to study conduct. Among completers, 8 were contact-lens wearers, 7 wore glasses, and 15 had uncorrected vision.

Visual Acuity. A trained evaluator conducted baseline and 2-week examinations. No test subject had a clinically relevant change in visual acuity.

Ophthalmologist Examinations and Call-In Comments. All subjects called after 1 week of use and reported no problems. The examining Ophthalmologist observed no test-article-related adverse effects at the 2-week post-use examination.

Daily Diary Comments. Subjects who commented made no negative safety-related diary comments.

11.0 Conclusions

A single-blind home-use test was conducted with 30 female subjects, 27% of whom were contact-lens wearers, who used EyeCrème twice daily for 2 weeks. The tested eye cream was found safe for use in the eye area; the claims “Ophthalmologist-Tested” and “Safe for Contact Lens Wearers” were considered supported.

Study Protocol

Clinical Evaluation of the Ophthalmologic Safety-in-Use of an Eye Cream

Tested product: EyeCrème.

Sponsor: SeneGence International, 19651 Alter, Foothill Ranch, CA 92610.

Sponsor Representative: Nikki Chew, Director, Research & Development.

Protocol date: November 16, 2021.

Footer: 799 Bloomfield Avenue · Verona, NJ 07044 · (973) 857-9541 · Fax (973) 857-9662.

Study Protocol — Clinical Evaluation of the Ophthalmologic Safety-in-Use of an Eye Cream

1.0 Objective

The objective was to evaluate eye-cream safety-in-use after 2 weeks, with pre- and post-test examinations by a Board-Certified Ophthalmologist, to support “Ophthalmologist-Tested” and “Safe for Contact Lens Wearers” in 30 female volunteers aged 18 to 69 years, approximately 25% of whom would be contact-lens wearers.

2.0 Sponsor

SeneGence International, 19651 Alter, Foothill Ranch, CA 92610. 2.1 Sponsor Representative: Nikki Chew, Director, Research & Development.

3.0 Clinical Investigators

• Medical Investigator: Lynda Youngworth, MD, Board-Certified Ophthalmologist.
• Principal Investigator: Toni F. Miller, PhD, DABT, BCFE, Scientific Director.
• Study Director: Gabriela Argueta, Project Manager.
• Study Coordinator: Jackson Hinden.

4.0 Clinical Testing Facility

Essex Testing Clinic, Inc., 799 Bloomfield Avenue, Verona, NJ 07044.

6.0 Study Dates

Start: November 22, 2021. End: December 6, 2021.

7.0 Ethics

7.1 Ethical Conduct. The study would follow Good Clinical Practice regulations in Title 21 of the U.S. Code of Federal Regulations, the Declaration of Helsinki, and/or Essex Testing Clinic Standard Operating Procedures.

7.2 Subject Information and Consent. The study would comply with CFR Title 21, Part 50. Written informed consent would be obtained before participation, and each subject would receive a copy.

8.0 Test Material

The Sponsor would supply the tested EyeCrème in individual containers suitable for the design.

8.1 Storage. Materials would be logged under clinic procedures, stored at room temperature in a secure area, and distributed only to entered subjects under investigator supervision.

8.2 Packaging and Labeling (Coding). The Study Sponsor would package and code the investigational materials consistently with the study design.

8.3 Disposition. Used articles would be disposed of after testing unless the Sponsor directed otherwise. Unused material would remain at the facility for 90 days; except for a retained sample, remaining portions would then be disposed of properly.

9.0 Study Design — 9.1 Subject Selection

Approximately 35 women aged 18 to 69 years and in general good health would be empanelled so at least 30 completed the study; approximately 25% would be contact-lens wearers. Each would read, understand, and sign an Informed Consent Form and complete a Medical History Form.

9.1.1 Inclusion Criteria

1. Women ages 18 to 69 years, in general good health, able to read, understand, and sign informed consent.
2. Willing to participate, follow directions, and stay for all 14 days.
3. Free of a skin or eye condition, or history of one, that might interfere with study purpose, conduct, or integrity.
4. Regular users of eye cream.

9.1.2 Exclusion Criteria

1. Failure to meet inclusion criteria.
2. Pregnant, planning pregnancy, or nursing.
3. Known sensitivity to skincare products.
4. Systemic or topical anti-inflammatory agents, except OTC acetaminophen, ibuprofen, or aspirin, during the 5 days before testing.
5. Unable to avoid those agents during the study, subject to the same exceptions.
6. Participation in another face or eye clinical study within 14 days before initiation.

9.0 Study Design Continued — 9.2 Test Procedure

Subjects would arrive with a freshly washed “clean face,” without face or eye-area cosmetics. A Board-Certified Ophthalmologist would examine all subjects on Day 1, including upper and lower eyelashes and margins, conjunctivae, visible corneal anomalies, slit-lamp examinations, and a general examination of the periorbital area.

A trained evaluator would conduct pre-test visual acuity. Individual data forms would record findings, and Medical History Forms would record contact-lens type.

After baseline, subjects would receive the test article and a daily diary. The diary would record each use date and time plus comments or observations.

Directions for Use

1. Use twice a day, morning and night.
2. Apply on upper eyelid and under eye.
3. Record use in diary.

Subjects would call after 7 days and as needed. After 2 weeks, they would return with remaining product and diaries for re-examination and post-test visual acuity.

9.3 Concomitant Usage of Eye/Face Products

Subjects had to use only the provided eye cream. They could not use another eye cream or introduce a new personal-care product or cosmetic on the face or around the eye area.

9.4 Adverse Reactions

Reported or observed adverse reactions would be reported promptly to the Principal and Medical Investigators; the Sponsor would be notified when appropriate. Study-related reactions would be recorded on the individual data form.

10.0 Record Retention

Essex Testing Clinic would retain study records for at least 2 years after submission of the Final Report.

11.0 Final Report

The protocol says that, within 4–5 weeks after the study, approximately January 10, 2021 as printed in the source, a Draft or Final Report would be submitted. It would cover design, summarized data, clinical observations, demographics, pertinent subjective comments such as stinging, burning, or itching, and an efficacy-oriented evaluation. It would include the Study Protocol, Informed Consent Form, Medical History Form, data sheets, and Daily Diary.

12.0 Acceptance of Protocol

The signatures represent that the protocol contained the details needed to conduct the study and that modifications required approval by both Sponsor and clinic.

• Toni F. Miller, PhD, DABT, BCFE, Scientific Director, Essex Testing Clinic — signed November 17, 2021.
• Nikki Chew, Director, Research & Development, SeneGence International — signed November 17, 2021.