check_circleStudy Completed
Sunscreening Agents
Bayer Identifier:
18271
ClinicalTrials.gov Identifier:
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
BothAge
18 - 60 YearsTrial summary
Enrollment Goal
83Trial Dates
May 2015 - May 2015Phase
N/ACould I Receive a placebo
NoProducts
BAY987516Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | St. Petersburg, 33714, United States |
Primary Outcome
- Subjective discomfortScore 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 articledate_rangeTime Frame:up to 10 daysenhanced_encryptionYesSafety Issue:
- Objective lacrimationScore 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 flowdate_rangeTime Frame:up to 10 daysenhanced_encryptionYesSafety Issue:
- Objective conjunctival inflammationScore 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 lidsdate_rangeTime Frame:up to 10 daysenhanced_encryptionYesSafety Issue:
- Objective cornea and iris inflammationScore 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 irisdate_rangeTime Frame:up to 10 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
4