Sunscreening Agents
Conditions
Keywords
Eye stinging potential
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.
Interventions
DRUGSPF 50 Y49 091 (BAY 987516)
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
DRUGSPF 50 X15 158 (BAY 987516)
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
DRUGSPF 50 X15 160 (BAY 987516)
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
DRUGSPF 50 X57 162 (BAY 987516)
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
OTHERJ & 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.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective discomfort | 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 |
| Objective lacrimation | 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 |
| Objective conjunctival inflammation | 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 |
| Objective cornea and iris inflammation | 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 |
Countries
United States
Outcome results
None listed