Clinical Claims Substantiation in Ophthalmology
Ensuring the safety and efficacy of ophthalmic products and cosmetic products used in and around the eyes is critical in today’s market. Clinical claims substantiation plays a pivotal role in establishing the reliability and credibility of these products, particularly when it comes to claims such as “Ophthalmologist Tested,” “No More Tears ” and “Safe for Contact Lenses” claims, as well as general testing for ocular irritation.
Ophthalmologist Tested Claims
When it comes to products that are used in and around the eyes, consumers trust products that have been tested and approved by professionals in the field. An “Ophthalmologist Tested” claim signifies that the product has undergone rigorous evaluation by ophthalmologists to ensure its safety and suitability for ocular use. This testing involves comprehensive assessments to verify the product’s compatibility with the eye, ensuring there are no adverse reactions or harm. Our substantiation process adheres to industry standards, conducting thorough evaluations that instill confidence in the product’s safety and reassure consumers..
No More Tears Claims (Ocular Instillation)
The promise of “No Sting” or “No Tears” is a major concern for consumers seeking comfort and safety in eye care products. The Ocular Instillation test, as recommended by industry guidelines, assesses the potential for discomfort or irritation when the product is used. Our methodologies evaluate formulations to ensure they are gentle and non-irritating, providing users with the reassurance of comfort while effectively addressing their eye care needs.
Ocular Irritation Studies
Ocular irritation studies are essential in determining the potential adverse effects of ophthalmic products on ocular tissues. Utilizing validated in-vitro models and protocols, our studies encompass a range of assessments to evaluate irritation, inflammation, and potential damage caused by the product to the eyes. This comprehensive approach aids in identifying any adverse effects early in the development phase, enabling timely adjustments to formulations and ensuring the ultimate safety and tolerability of the product upon market release.
Safe for Contact Lenses Claims
For individuals who wear contact lenses, ensuring that products will not damage the lenses or the eye is vital. Claims of being “Safe for Contact Lenses” run as part of a safety in use Ophthalmologist Tested study, require specialized testing procedures to confirm that the product does not interfere with the integrity, comfort, or function of contact lenses. Our claims substantiation process includes evaluations to ensure that the product is compatible with contact lenses, providing users with the confidence to use these products without compromising the performance or safety of their contacts.
Our Methodology
At CPT℠ Labs, we prioritize the highest standards in clinical claims substantiation for ophthalmic products. Our approach integrates industry-standard methodologies and best practices, where our team of highly experienced professionals delivers comprehensive and reliable assessments.
The components of our methodology include:
Comprehensive Testing Protocols
We follow established industry guidelines and regulatory standards in conducting in vitro studies to comprehensively evaluate products used in and around the eyes.
In-vitro Validated Models
Utilizing validated models and assays, we ensure the reliability and accuracy of our assessments, providing precise data for informed decision-making.
Collaboration with Experts
Our seasoned ophthalmologists, scientists, and industry experts ensure that our evaluations align with the latest advancements and best practices in the field.
Adherence to Regulatory Requirements
Our processes adhere to regulatory requirements, guaranteeing that our clients meet compliance standards and deliver safe and effective products to the market.
Why Choose CPT℠ Labs
In ophthalmic product development, substantiating clinical claims is fundamental in gaining consumer trust and ensuring product safety. Our commitment to excellence in clinical claims substantiation underscores our dedication to delivering ophthalmic products that are safe, effective, and trustworthy to the public. With nearly 50 years of industry-leading testing, we are the choice for testing your ophthalmic products.
Contact us today to learn more about how our specialized services in ophthalmological testing and claim substantiation can elevate the credibility and reliability of your eye care products.
Our Departments
Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:
- Clinical — Efficacy trials can be performed for safety, consumer in-use, and to support claims such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
- In-Vitro Toxicology — Our In-Vitro Toxicology department assists clients when they are looking to perform non-animal (animal-free) toxicology testing.
- Microbiology — Microbial contamination and preservative efficacy testing are key to cosmetic and OTC drug products.
- Photobiology — From SPF and Water-Resistant claims to Photoallergy and Phototoxicity studies, CPT℠ is the world leader in sunscreen testing.
- Analytical — From raw materials, product batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.
- Consulting – Our consulting staff can perform GMP and GLP audits of your facilities or vendors, help create SOPs, develop testing programs, etc.
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Please Note: CPT℠ only performs testing for companies. We do not perform product testing for the general public.