Trial Condition(s):
Sunscreening Agents
To evaluate Eye Installation-Tear Free
Bayer Identifier:
18271
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
83
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site St. Petersburg, United States, 33714 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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 articleTimeframe: up to 10 days
- 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 flowTimeframe: up to 10 days
- 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 lidsTimeframe: up to 10 days
- 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 irisTimeframe: up to 10 days
Additional Information
Copyright © Bayer
Powered by
