Sunscreen AgentsNCT02872207
Evaluation of the Stinging Potential in Human Eyes
A study testing BAY 987516 (Y65-122) and BAY 987516 (Y65-118) in people with Sunscreen Agents, run by Bayer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreen Agents
- What is being tested?
- BAY 987516 (Y65-122) and BAY 987516 (Y65-118)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2015to 22 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sunscreen Agents
- Being tested
- BAY 987516 (Y65-122), BAY 987516 (Y65-118), Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 987516 (Y65-122)Drug
5 µL in one eye
BAY 987516 (Y65-118)Drug
5 µL in one eye
ControlDrug
5 uL in other eye
| Study group | Role | What they receive |
|---|---|---|
| Suncare agent 1 + control | Experimental | Application of control and test product into one of the subjects two eyes. Receives: Drug: BAY 987516 (Y65-122); Drug: Control |
| Suncare agent 2 + control | Experimental | Application of control and test product into one of the subjects two eyes. Receives: Drug: BAY 987516 (Y65-118); Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
Measured: up to 24 hours
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Measured: up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Measured: at 24 hours
Post installation pain/stinging was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation itching was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation dryness was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation scratchiness was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation discomfort upon awakening was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
Measured: at 24 hours
Post installation pain in bright sunlight was assessed using a 5-category intensity score
Measured: at 24 hours
Secondary outcomes (1)
Number of adverse events as a measure of safety and tolerabilitay
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start21 Feb 2015
- Primary completion22 Feb 2015
- Study completion22 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sunscreen AgentsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872207
- Sponsor's protocol ID
- 18196
- Status last verified
- Dec 2018
- First submitted
- 5 Aug 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stinging Potential in Human Eyes
- ClinicalTrials.gov ID
- NCT02872207
- Acronym / sponsor ID
- 18196
- Conditions
- Sunscreen Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2015 (actual)
- Primary completion
- 22 Feb 2015 (actual)
- Study completion
- 22 Feb 2015 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suncare agent 1 + control | Experimental | Drug: BAY 987516 (Y65-122), Drug: ControlApplication of control and test product into one of the subjects two eyes. |
| Suncare agent 2 + control | Experimental | Drug: BAY 987516 (Y65-118), Drug: ControlApplication of control and test product into one of the subjects two eyes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 987516 (Y65-122)5 µL in one eye | Drug | Suncare agent 1 + control |
| BAY 987516 (Y65-118)5 µL in one eye | Drug | Suncare agent 2 + control |
| Control5 uL in other eye | Drug | Suncare agent 1 + control, Suncare agent 2 + control |
Primary outcome
Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
Time frame: up to 24 hours
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time frame: up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time frame: at 24 hours
Post installation pain/stinging was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation itching was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation dryness was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation scratchiness was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation discomfort upon awakening was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation pain in bright sunlight was assessed using a 5-category intensity score
Time frame: at 24 hours
1 secondary outcome
Number of adverse events as a measure of safety and tolerabilitay
Time frame: at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAY 987516 (Y65-122) and BAY 987516 (Y65-118) in people with Sunscreen Agents, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale. (time frame: up to 24 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.