Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02872207
Other study ID # 18196
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2015
Est. completion date February 22, 2015

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 22, 2015
Est. primary completion date February 22, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Male or female subjects, aged 18 to 60 years

- No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist

- Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study

- Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements

- Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.

- Subjects should refrain from use of make-up on testing day

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY 987516 (Y65-122)
5 µL in one eye
BAY 987516 (Y65-118)
5 µL in one eye
Control
5 uL in other eye

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale. up to 24 hours
Primary Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories up to 24 hours
Primary Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories at 24 hours
Primary Post installation pain/stinging was assessed using a 5-category intensity score at 24 hours
Primary Post installation itching was assessed using a 5-category intensity score at 24 hours
Primary Post installation dryness was assessed using a 5-category intensity score at 24 hours
Primary Post installation scratchiness was assessed using a 5-category intensity score at 24 hours
Primary Post installation discomfort preventing sleep was assessed using a 5-category intensity score at 24 hours
Primary Post installation discomfort upon awakening was assessed using a 5-category intensity score at 24 hours
Primary Post installation excessive discharge upon awakening was assessed using a 5-category intensity score at 24 hours
Primary Post installation pain in bright sunlight was assessed using a 5-category intensity score at 24 hours
Secondary Number of adverse events as a measure of safety and tolerabilitay at 24 hours
See also
  Status Clinical Trial Phase
Completed NCT02872194 - Evaluation of the Stinging Potential of Products in Human Eyes N/A
Completed NCT05004168 - Sun Protection Factor (SPF) / UVA Protection Factor Study N/A
Completed NCT02857738 - Sun Protection Factor (SPF) - Static and Water Resistant Assay N/A
Completed NCT02872246 - Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay N/A
Completed NCT02872233 - Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay N/A
Completed NCT02857725 - Sun Protection Factor (SPF) Assay N/A
Completed NCT02857478 - Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users N/A
Completed NCT02885805 - Sun Protection Factor (SPF) Efficacy Assay N/A
Completed NCT02869113 - Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes N/A
Completed NCT02802930 - Test the Phototoxicity of Sunscreen Products N/A