Eight-Week Consumer Perception Evaluation of an Eyelash and Eyebrow Serum
If you are eligible for the study and you choose to participate, you will:
PROCEDURES: EYELASH AND EYEBROW SERUM Visit 1: Potential subjects will report to the Testing Facility at their scheduled appointment time, with a freshly washed face, without moisturizers or makeup, and complete an ICF to become subjects. Subjects will complete a Medical History Form to determine initial qualification. Subjects will sign a Photographic Release Form. Subjects will be administered a baseline Sponsor-supplied questionnaire. An Expert Grader will evaluate each subject’s eye and brow area for evidence of redness, swelling, dryness, and any other anomalies. Subjects presenting a score of moderate (2) or greater for any one parameter will be disqualified. For qualification purposes, an Expert Grader will also evaluate each subject’s eyelashes and eyebrows for evidence of any degree of sparseness (thin, less dense, and/or widely spaced) at each test site. Subjects will be disqualified if any test site does not appear sparse. Subjects will be screened by a Board-Certified Ophthalmologist to determine qualification. The Ophthalmologist will study and evaluate by gross and/or slit lamp examination each subject’s eyelids, conjunctivae, corneas, anterior chambers, and pupillary reactions, in addition to measuring visual acuity. Subjects must have an acceptable ophthalmic examination to ensure eye health and if appropriate, the correct fit and condition of their contact lenses. Qualified subjects will acclimate, at room temperature conditions, for at least 15 minutes. A Bioinstrumentation technician will capture 2-D images of the eye region. Subjects will be provided with pre-weighed test materials (one for lash and one for brow) and a daily diary to document use. Each subject will be instructed to use the test material following Sponsor supplied use instructions. Subjects must agree to use only the test materials for all eyelash and eyebrow enhancement purposes for the duration of the trial. Mascara, eyelash, and eyebrow treatments (such as eyelash lifts, eyelash extensions, and eyelash/brow tints) will be prohibited during the trial. Subjects may wear their usual facial makeup products during the trial. Subjects may not introduce any new cosmetic, toiletry, or personal care products during the course of the trial. Visit 2: After 4 weeks of test material use, subjects will report to the Testing Facility at their scheduled appointment time with a freshly washed face, without moisturizers or makeup. Daily diaries will be reviewed, and test materials will be weighed for compliance and returned to each subject. Subjects will acclimate to room temperature conditions for at least 15 minutes. While acclimating, the Expert Grader and Board-Certified Ophthalmologist will conduct evaluations on each subject, as previously described. Subjects will be administered a Sponsor-Supplied questionnaire to complete. The questionnaire will be reviewed for completeness during the visit. After acclimation, a Bioinstrumentation technician will capture 2-D images of the eye region, as previously described. Visit 3: After 8 weeks of test material use, subjects will report to the Testing Facility at their scheduled appointment time with a freshly washed face, without moisturizers or makeup. Daily diaries will be reviewed for completion, and test materials will be re-weighed and collected. Subjects will acclimate to room temperature conditions for at least 15 minutes. While acclimating, the Expert Grader and Board-Certified Ophthalmologist will conduct evaluations on each subject, as previously described. Subjects will be administered a Sponsor-Supplied questionnaire to complete. The questionnaire will be reviewed for completeness during the visit. After acclimation, a Bioinstrumentation technician will capture 2-D images of the eye region, as previously described. Subjects will then be dismissed from the trial. *No eye makeup or moisturizer is to be worn to Testing Facility visits. Mascara, eyelash, and eyebrow treatments (such as eyelash lifts, eyelash extensions, and eyelash/brow tints) will be prohibited during the trial. Subjects may wear their usual facial makeup products during the trial. Subjects may not introduce any new cosmetic, toiletry, or personal care products during the course of the trial.
70 New Dutch Lane, Fairfield, NJ
973-359-5879
Monday - Thursday: 7:30AM - 7:30PM
Friday: 7:30AM - 7:00PM