check_circleStudy Completed

Sunscreening Agents

Bayer Identifier:

18271

ClinicalTrials.gov Identifier:

NCT02802917

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate Eye Installation-Tear Free

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years
  • - 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.

Trial summary

Enrollment Goal
83
Trial Dates
May 2015 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987516
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    up to 10 days
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 10 days
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 10 days
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 10 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Evaluation of the stinging potential of products in human eyes
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.