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Completed

NCT Number: NCT02802917

To Evaluate Eye Installation-Tear Free

The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.

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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

  • Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
  • Subjects not under any doctor's care for ocular or peri orbital diseases
  • The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.

Treatment and study plan

SPF 50 Y49 091 (BAY 987516)

Drug

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X15 158 (BAY 987516)

Drug

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X15 160 (BAY 987516)

Drug

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X57 162 (BAY 987516)

Drug

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

J & J baby shampoo, X46 046 (control)

Other

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Primary outcomes

  1. Subjective discomfort

    Time frame: up to 10 days

    Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article

  2. Objective lacrimation

    Time frame: up to 10 days

    Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow

  3. Objective conjunctival inflammation

    Time frame: up to 10 days

    Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids

  4. Objective cornea and iris inflammation

    Time frame: up to 10 days

    Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Evaluation of the Stinging Potential of Products in Human Eyes

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 16, 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.

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