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This study evaluated a new facial sunscreen's ocular tolerance using a three-tiered approach. The water-based sunscreen demonstrated good eye safety, comparable to baby shampoo, suggesting it is well-tolerated for ocular use.

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Area of Science:

  • Ophthalmology
  • Dermatology
  • Toxicology

Background:

  • Poor ocular tolerance of sunscreens leads to low compliance.
  • A novel three-tiered testing strategy was developed for ocular tolerance assessment.
  • This strategy includes in vitro irritation, in vitro pain receptor activation, and in vivo clinical studies.

Purpose of the Study:

  • To evaluate the ocular tolerance of a new water-based facial sunscreen (SCFW).
  • To validate a three-tiered approach for assessing sunscreen ocular tolerability.

Main Methods:

  • Tier 1: In vitro EpiOcular™ assay for ocular irritation potential.
  • Tier 2: In vitro NociOcular assay to measure TRPV1 activation (pain receptor potential).
  • Tier 3: In vivo clinical study involving ocular instillation and ophthalmologic evaluation.

Main Results:

  • SCFW showed minimal cytotoxicity in the EpiOcular™ assay, indicating low irritation potential.
  • SCFW exhibited minimal TRPV1 activation in the NociOcular assay, suggesting low sting potential.
  • Clinical study results demonstrated ocular tolerability comparable to 10% baby shampoo.

Conclusions:

  • SCFW possesses negligible ocular irritation and minimal pain receptor activation potential.
  • The new facial sunscreen exhibits good ocular tolerability, similar to a mild control.
  • The described tiered approach effectively evaluates ocular tolerability for facial sunscreens.