To Evaluate Eye Installation-Tear Free

Sunscreening Agents Clinical Trial

Official title:

Evaluation of the Stinging Potential of Products in Human Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802917
• Other study ID #: 18271
• Status: Completed
• Phase: N/A
• Start date: May 15, 2015
• Est. completion date: May 24, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 24, 2015
• Est. primary completion date: May 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• SPF 50 Y49 091 (BAY 987516)
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)
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)
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)
5 µL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Other:
• J & J baby shampoo, X46 046 (control)
5 µL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective discomfort	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	up to 10 days
Primary	Objective lacrimation	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	up to 10 days
Primary	Objective conjunctival inflammation	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	up to 10 days
Primary	Objective cornea and iris inflammation	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	up to 10 days

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