Skip to main content
OpenTrials
Completed

NCT Number: NCT02854137

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Evaluation of the human eye irritation potential of a test sunscreen formulation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sunscreening Agents

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
  • Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
  • Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
  • Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.

Exclusion criteria

  • Subjects have ocular disease or peri-orbital dermatitis or trauma.
  • Subjects have a systemic illness which contra-indicates participation.
  • Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
  • Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.

Treatment and study plan

BAY987521

Drug

10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).

Control

Drug

10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.

Primary outcomes

  1. Macroscopic evaluations for Lacrimation (score 0-4)

    Time frame: up to 1 hour post instillation

  2. Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)

    Time frame: up to 1 hour post instillation

  3. Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)

    Time frame: up to 1 hour post instillation

  4. Subjective assessment of discomfort (score 0-4)

    Time frame: up to 1 hour post instillation

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2016
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.