To Evaluate Eye Installation-Tear Free

• ClinicalTrials.gov Identifier: NCT02802917
• Recruitment Status: Completed
• First Posted: June 16, 2016
• Last Update Posted: December 12, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sunscreening Agents	Drug: SPF 50 Y49 091 (BAY 987516); Drug: SPF 50 X15 158 (BAY 987516); Drug: SPF 50 X15 160 (BAY 987516); Drug: SPF 50 X57 162 (BAY 987516); Other: J & J baby shampoo, X46 046 (control)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Evaluation of the Stinging Potential of Products in Human Eyes
• Actual Study Start Date: May 15, 2015
• Actual Primary Completion Date: May 24, 2015
• Actual Study Completion Date: May 24, 2015

Arms and Interventions

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.	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.; 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 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.	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.; 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 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.	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.; 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Saint Petersburg, Florida, United States, 33714

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02802917
• Other Study ID Numbers: 18271
• First Posted: June 16, 2016
• Last Update Posted: December 12, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Eye stinging potential