Sunscreening AgentsNCT02854137
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
A study testing BAY987521 in people with Sunscreening Agents, run by Bayer at 1 site in United States.
Trial summary
Evaluation of the human eye irritation potential of a test sunscreen formulation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreening Agents
- What is being tested?
- BAY987521
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2015to 14 Oct 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
- Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
- Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
- Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
- Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.
Who cannot join
- Subjects have ocular disease or peri-orbital dermatitis or trauma.
- Subjects have a systemic illness which contra-indicates participation.
- Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the human eye irritation potential of a test sunscreen formulation.
- Conditions
- Sunscreening Agents
- Being tested
- BAY987521, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987521Drug
10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).
ControlDrug
10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen / Arm 1 | Experimental | Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye. Receives: Drug: BAY987521 |
| Control | Other | A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopic evaluations for Lacrimation (score 0-4)
Measured: up to 1 hour post instillation
Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
Measured: up to 1 hour post instillation
Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
Measured: up to 1 hour post instillation
Subjective assessment of discomfort (score 0-4)
Measured: up to 1 hour post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start14 Oct 2015
- Primary completion14 Oct 2015
- Study completion14 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sunscreening 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 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
- NCT02854137
- Sponsor's protocol ID
- 18434
- Status last verified
- Dec 2018
- First submitted
- 29 Jul 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 Irritation Potential of Sunscreen Products in Human Eyes
- ClinicalTrials.gov ID
- NCT02854137
- Acronym / sponsor ID
- 18434
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 14 Oct 2015 (actual)
- Study completion
- 14 Oct 2015 (actual)
- First posted
- 3 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.
Evaluation of the human eye irritation potential of a test sunscreen formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunscreen / Arm 1 | Experimental | Drug: BAY987521Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye. |
| Control | Other | Drug: ControlA trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
- Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
- Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
- Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.
Key exclusion criteria (4 listed)
- Subjects have ocular disease or peri-orbital dermatitis or trauma.
- Subjects have a systemic illness which contra-indicates participation.
- Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.
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 |
|---|---|---|
| BAY98752110 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103). | Drug | Sunscreen / Arm 1 |
| Control10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye. | Drug | Control |
Primary outcome
Macroscopic evaluations for Lacrimation (score 0-4)
Time frame: up to 1 hour post instillation
Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
Time frame: up to 1 hour post instillation
Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
Time frame: up to 1 hour post instillation
Subjective assessment of discomfort (score 0-4)
Time frame: up to 1 hour post instillation
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.
Related trials for Sunscreening Agents
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A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
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Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
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Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
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Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
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 BAY987521 in people with Sunscreening 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 4 inclusion and 4 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?
Macroscopic evaluations for Lacrimation (score 0-4) (time frame: up to 1 hour post instillation). The study lists 4 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.