P147 BIO UNDER EYE BALM FOR WOMEN


P147 BIO UNDER EYE BALM FOR WOMEN
Posted  May 25, 2021

START DATE06/15/2021
QUALIFICATIONSWomen Ages 35 to 65
TIME REQUIREMENT6 Visits - 3 of the visits are on the same day
COMPENSATION$300

NOTES: PRESCREENING IS REQUIRED with a clean, make-up free face. 
* Must have fine lines and wrinkles in the crows feet area, sagging and puffiness of skin in the eye area.
* Contact Lens wearers must wear contacts to visits.
* No tattoo cosmetics and/or fake eyelashes.
* Visits 2, 3 and 4 on this study will take place on the same day: Visit 2 between 7 & 9:15 a.m., then 6 and 8 hours post product application.
* You must wear a face mask/covering while at ECRL except when requested to remove it for acclimation and photos.
* Children, purses or other personal bags are not permitted in the facility at this time.

Study Times:
Visit 1: Between 8 a.m. and 10:40 a.m.
Visit 2 will be scheduled between 7 a.m. and 9:15 a.m. with the Bio department. Visits 3 & 4 will take place on the same day at 6 and 8 hours post application.
Visits 5 & 6 will be scheduled between 8 a.m. and 3:20 p.m.

Group 2:
Visit 1:  Tuesday, 6/15 – 45 minutes
Visit 2: Tuesday, 6/22 – 2 hours
Visit 3 & 4: Same day as Visit 2 – 6 and 8 hours post application – 30 minutes each
Visit 5: Tuesday, 7/20 – 1 hour
Visit 6: Tuesday, 8/3 – 1 hour

Group 3:
Visit 1:  Thursday, 6/17 – 45 minutes
Visit 2: Thursday, 6/24 – 2 hours
Visit 3 & 4: Same day as Visit 2 – 6 and 8 hours post application – 30 minutes each
Visit 5: Thursday, 7/22 – 1 hour
Visit 6: Thursday, 8/5 – 1 hour

Group 4:
Visit 1:  Friday, 6/18 – 45 minutes
Visit 2: Friday, 6/25 – 2 hours
Visit 3 & 4: Same day as Visit 2 – 6 and 8 hours post application – 30 minutes each
Visit 5: Thursday, 7/22 – 1 hour
Visit 6: Thursday, 8/5 – 1 hour

Inclusion Criteria:
1. Subject is a female between 35-65 years of age;
2. Subject is a contact lens wearer (approximately 50%) and non-contact lens wearer (approximately 50%);
3. Subject has sensitive eyes (approximately 50%) and/or has non-sensitive (normal) eyes (approximately 50%),
4. Subject has sensitive skin (approximately 50%) and/or has normal skin (approximately 50%),
5. Subject must have mild to moderate fine lines and wrinkles in the crows’ feet area, sagging of skin in eye area, puffiness of skin in eye area;
6. Subject agrees to remove face mask for the acclimation period (for approximately
15 minutes within socially distanced proximity of other subjects) and for study evaluations (including image captures), and to replace the face mask as directed by study staff;
7. Subject agrees to use the non-moisturizing soap during the conditioning phase;
8. Subject agrees to refrain from drinking caffeinated drinks at least two hours prior to each study visit;
9. Subject agrees to not wash or rinse the test material off of the test sites until after the 8 hour return visit;
10. Subject’s best corrected visual acuity is better than 20/200 at the baseline evaluation;
11. Subject reports no subjective ophthalmic irritation at the baseline evaluation;
12. Subject exhibits baseline lacrimation, eyelid, contact lens, and corneal scores of 0. Subject may exhibit slight or mild [level 1 or 2] irritation of the palpebral and/or bulbar conjunctivae at the baseline evaluation. This latitude is permitted to allow for those subjects who normally exhibit slight or mild irritation as a result of their contact lens wear, and/or environmental and seasonal factors;
13. Subject agrees not to introduce any new cosmetic or toiletry products during the study
14. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits.
15. Subject is willing to participate in all study evaluations.
16. Subject is in generally good health and has a current Panelist Profile Form on file at ECRL.
17. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study.
18. Subject has signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
19. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.

Exclusion Criteria:
1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study;
3. Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study;
4. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
5. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
6. Subject does not exhibit any rashes, scratches or burn marks on the test site (face);
7. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
8. Subject has diabetes.




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