MedDataX Logo

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

NCT ID: NCT02854137

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-14

Study Completion Date

2015-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sunscreening Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sunscreen / Arm 1

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.

Group Type EXPERIMENTAL

BAY987521

Intervention Type 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

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.

Group Type OTHER

Control

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAY987521

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

Intervention Type DRUG

Control

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Petersburg, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18434

Identifier Type: -

Identifier Source: org_study_id