Evaluation of the Stinging Potential in Human Eyes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02872207

Enrollment

Registered

2016-08-19

Start date

2015-02-21

Completion date

2015-02-22

Last updated

2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sunscreen Agents

Brief 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.

Interventions

DRUGBAY 987516 (Y65-122)

5 µL in one eye

DRUGBAY 987516 (Y65-118)

5 µL in one eye

DRUGControl

5 uL in other eye

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

* 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

Design outcomes

Primary

Measure	Time frame
Post installation pain in bright sunlight was assessed using a 5-category intensity score	at 24 hours
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
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories	up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories	at 24 hours
Post installation pain/stinging was assessed using a 5-category intensity score	at 24 hours
Post installation itching was assessed using a 5-category intensity score	at 24 hours
Post installation dryness was assessed using a 5-category intensity score	at 24 hours
Post installation scratchiness was assessed using a 5-category intensity score	at 24 hours
Post installation discomfort preventing sleep was assessed using a 5-category intensity score	at 24 hours
Post installation discomfort upon awakening was assessed using a 5-category intensity score	at 24 hours
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score	at 24 hours

Secondary

Measure	Time frame
Number of adverse events as a measure of safety and tolerabilitay	at 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026