Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

NCT02854137 | Completed

• 1 other identifier: 18434
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (4)

• Macroscopic evaluations for Lacrimation (score 0-4)

  up to 1 hour post instillation

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

  up to 1 hour post instillation

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

  up to 1 hour post instillation

• Subjective assessment of discomfort (score 0-4)

  up to 1 hour post instillation

Study Arms (2)

Sunscreen / Arm 1

EXPERIMENTAL

Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye.

Drug: BAY987521

Control

OTHER

A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper.

Drug: Control

Interventions

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).

Sunscreen / Arm 1

Control DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 3, 2016
• Study Start: October 14, 2015
• Primary Completion: October 14, 2015
• Study Completion: October 14, 2015
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)