To Evaluate Eye Installation-Tear Free

Evaluation of the Stinging Potential of Products in Human Eyes

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.

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: SPF 50 Y49 091 (BAY 987516); Other: J & J baby shampoo, X46 046 (control); Drug: SPF 50 X15 158 (BAY 987516); Drug: SPF 50 X15 160 (BAY 987516); Drug: SPF 50 X57 162 (BAY 987516)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPF 50 Y49 091; Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.	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.; 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.
Experimental: SPF 50 X15 158; Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.	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.; Drug: 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.
Experimental: SPF 50 X15 160; Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.	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.; Drug: 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.
Experimental: SPF 50 X57 162; Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): May 24, 2015
• Study Completion (Actual): May 24, 2015

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Eye stinging potential
• Other Study ID Numbers: 18271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No