Under Eye Clinical Testing And Claim Support

Dark Circle Reduction, Under Eye Bags, And Ophthalmological Claim Support

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Published by our sponsorsSee case studies

Mineral sunscreen whitening study, NCT05565625 ↗

Skin hydration and health study ↗

18-week hyperpigmentation study, NCT07136766 ↗

12-week eye cream study, NCT05807620 ↗

Two close-up images of the under-eye area: top is Baseline with a blue border; bottom is Week 6 with a green border, showing fine lines and a small mole near the lower lid.

Don’t Let Your Customers Settle For Tired, Puffy, And Sad Looking Eyes

Since the eyes are a main focal point of the face, people tend to take extra care to ensure that the area that frames them is well-kept and looking its best.

While the long-term effects of UV exposure, pollution, and the environment are unavoidable, there are numerous products designed to minimize the effects and appearance of aging and to make sure your eye area appears healthy and radiant.

See under-eye and crow’s feet cases in the gallery →

Dark Undereye Circle And Puffiness Reduction

Dark under eye circles and under eye puffiness are synonymous with tired, older looking eyes and are universally undesirable. These conditions can also be extremely difficult to improve.

Most people want to appear younger and well rested, and combating under eye circles and puffiness has become a thriving multibillion dollar international industry.

Those with a genetic disposition known as periorbital hyperpigmentation
Individuals who are not getting enough sleep
Individuals who have anxiety and/or depression
Those with Fitzpatrick Skin Types IV, V, and VI (darker complexions)
Those over 60 years old

Though dark circles and puffiness can affect anyone, they are most prevalent in certain individuals including:

Reduction mechanisms include cosmetic cover up and blending combined with longer term treatments designed to improve overall skin health and appearance.

Most under eye products are not classified as OTC drugs in the current market but claims are constantly changing and it is extremely important that you consult your legal team for final label claims.

Ophthalmologist “In Use” Safety Testing

Ophthalmologist “In Use” Safety testing is an excellent way to ensure that your product doesn’t irritate the skin and the sensitive area around the eyes. These tests can be combined with most of our other claim support techniques at VCS, and they provide an excellent safety plus efficacy hybrid clinical study design.

With these studies, products designed for use around the eye area (toners, moisturizers, serums, etc) are distributed to a test panel and subjects are evaluated by a board-certified Ophthalmologist. The doctor assesses multiple conditions of the eyes and scores each individual eye for signs of irritation using a slit lamp.

The evaluations can occur at a variety of timepoints depending on the particular product use instructions and expectations for product use.

Any irritations are noted in detail, including severity, location, and secondary parameters including upper/lower lid positioning, palpebral conjunctiva, and bulbar conjunctiva.

These studies are often combined with Sensory Feedback Questionnaires which provide additional data on the subjects’ interaction with the products and their performance.

These studies provide substantiated support for the claims “Ophthalmologist Tested” or “Ophthalmologist Approved,” however as with all individual final label claims it’s imperative that you review them with your legal and marketing teams.

”No Tears” and Direct Instillation Techniques

You may have a product that requires direct Installation clinical testing that will prove that your ingredients are safe for use when in direct contact with human eyes, whether the product is intended for direct use or not.

Typically, this test is run on a panel of 12 healthy female and male subjects to evaluate the comparative eye irritation potential of 1 test article plus a standard control.

The Consultant Ophthalmologist facilitates slit lamp assessments instantly prior to, during & after the test article’s direct installation which has been appropriately diluted.

The study is based on the original published Johnson’s Baby Shampoo Clinical Study, which has been a tried-and-true industry method since the 1950s.

The “No Tears” direct installation test is run by a licensed Ophthalmologist and will allow you to make label claims such as “Ophthalmologist Tested, Ophthalmologist Approved, No Tears, Kind to Eyes, Safe for Eyes.”

Please contact VCS for more information on this and other Ophthalmologic Testing.

Under eye skin texture at baseline and week 6

Expert Clinical Grading

Trained graders score visible change

Supports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”

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Biomarkers and Microbiome

Tape strips, swabs and collections

Supports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”

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Biophysical Instrumentation

Hydration, TEWL, elasticity, color

Supports claims like “Hydrates by up to 87% in as little as one use”

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Peer-Reviewed Writing

Clinical and scientific publications

Scientifically validated study summaries for publication in peer-reviewed medical journals

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Before and After Photography

Controlled, reproducible clinical imaging

Supports claims like “Up to a 44% reduction in redness in as little as 2 weeks”

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Consumer Perception

Panelist questionnaires and self-assessment

Supports claims such as “97% of women agreed their skin felt smoother and more supple”

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Under eye dark circles at baseline and T6

Eye Area Anti Aging and Wrinkle Reduction Testing

Along with puffiness and dark circles, the tender under eye area is also extremely susceptible to other visual signs of aging such as fine lines and wrinkles.

This area is one of the most common locations for fine lines and wrinkles to develop, and the eye area is a particularly densely populated region for the visible signs of aging.

By helping to make these conditions less visible or by affecting properties of the skin such as elasticity and firmness, it’s possible for a product to make people appear younger and more well- rested.

Wrinkles and Fine Lines are a particularly common theme with anti-aging products, and with the right clinical support, it is possible to demonstrate quantified, percentage-based claims and/or self-perceived, sensory claims.

UVC Implications

The Under eye area’s hydration plays a major role in the appearance of youthfulness and health, and as far as prevention is concerned it is the second most important thing that people should consider after SPF and sun protection.

Under Eye moisturization can help reduce the appearance of fine lines and wrinkles as well as under eye puffiness. The most effective anti-aging ingredients tend to have a drying effect, so moisturization is an incredibly important component for under eye and eye area products in general.

Please visit our Moisturization and Hydration Testing page for more specific information.

Under Eye Clinical and Claim Support Validation Techniques

Under eye Claims can be supported through a multitude of Validated Claim Support’s clinical techniques, including Before and After Photography, Biophysical Instrumentation, Expert Objective Grading, and Subjective Consumer Perception.

It is important to note that there are many additional variables which come into play with the body as a whole and the impact that diet, exercise, stress, and sleep have on the skin as a whole than topical products.

Custom Protocol are available to test conditions such as:

Supports Maintaining a Youthful Appearance
Reduction In the Appearance of Fine Lines and Wrinkles
Dark Under Eye Circle Reduction
Reduces Under Eye Puffiness
Ophthalmologically Tested
Safe for Contact Lens Wearers
Improvement In Skin Firmness
Radiant, Even Skin Tone
Healthy, Youthful Appearance

Please note that the secondary claims noted above may or may not be approved by regulatory bodies throughout the world. Always consult your legal team when developing your claims.

Clinical photography

Before & After Photography: Custom Teaneck NJ Studio

Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support uses high-resolution clinical photography to document how a product performs over a treatment timeline or product usage cycle.

See our before and after photography Get a quote See the gallery

BaselineWeek 2

Redness reduction: 44% less redness from baseline to week 2. The lower circle shows the average skin color in the treated area. Drag to compare.

Before and after case studies

Hair Growth Efficacy And Clinical Density Improvement →

Hair Density And Hair Growth Clinical Imaging Side Profile →

Acne lesion, baseline compared with result

Full Face Acne Reduction Lesions With Analysis →

Dry Scalp And Dandruff Improvement Clinical Study Photo →

Anti-Aging, Wrinkle Reduction And Clinical Claim Support Imaging →

Full Face Before And After Anti-Aging And Fine Line Reduction →

Pore Size Reduction Clinical Photograph →

Blemish redness, baseline compared with day 3

High Resolution Redness Reduction →

What panelists are asked

At each visit, panelists rate statements like these on a five-point scale. Each statement is written to match a claim you want to make, and the result is reported as the percentage of panelists who agreed (Strongly Agree plus Agree).

Strongly agreeAgreeNeitherDisagreeStrongly disagree

My dark circles look brighter.
My fine lines and crow's feet are minimized.
My eyes look less tired and more awake.
My eye area looks more hydrated.
This product works well applied under makeup.

Example statements from VCS questionnaire templates. Final wording is agreed with you in the protocol.

Where to next

Keep exploring

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Start a Conversation About Your Product Study

Tell us about your product, your intended claims, and your timeline. Our business development team will review your needs and follow up with a customized proposal, typically within one business day. There is no cost for the initial consultation or study design review.

Get a quote Call (201) 331-9300

FAQ

Under Eye Studies: frequently asked questions

What under eye claims can Validated Claim Support test?

Validated Claim Support runs custom under eye studies for dark circle reduction, under eye puffiness and bags, fine lines and wrinkles, skin firmness, radiant and even skin tone, a youthful appearance, "Ophthalmologically tested" and "Safe for contact lens wearers." Claims are supported with before and after photography, biophysical instrumentation, expert objective grading and subjective consumer perception.

Are under eye products classified as OTC drugs?

Most under eye products are not classified as OTC drugs in the current market, but claims are constantly changing. Validated Claim Support recommends consulting your legal team on final label claims, since some secondary claims may or may not be approved by regulatory bodies around the world.

What is ophthalmologist "in use" safety testing?

Products designed for use around the eyes, such as toners, moisturizers and serums, are given to a test panel, and a board-certified ophthalmologist evaluates each eye with a slit lamp for signs of irritation at set timepoints. Any irritation is recorded in detail. These studies support claims such as "Ophthalmologist tested" or "Ophthalmologist approved."

What is direct instillation or "no tears" testing?

Direct instillation testing shows that ingredients are safe in direct contact with human eyes. It typically runs on a panel of 12 healthy male and female subjects, comparing the eye irritation potential of 1 test article with a standard control. A consultant ophthalmologist performs slit lamp assessments before, during and after the diluted test article is instilled.

Can safety and efficacy be tested in the same under eye study?

Yes. Ophthalmologist in use safety testing can be combined with most of Validated Claim Support's other claim support techniques, giving a hybrid safety and efficacy study design. These studies are often paired with sensory feedback questionnaires for additional data on how subjects experienced the product.

Who is most affected by dark circles and puffiness?

Dark circles and puffiness can affect anyone, but they are most prevalent in people with a genetic disposition known as periorbital hyperpigmentation, people who are not getting enough sleep, people with anxiety or depression, people with Fitzpatrick skin types IV, V and VI, and people over 60 years old.