Sunscreening AgentsNCT02728856
Evaluation of the Irritation Potential of Products in Human Eyes.
A study testing Sunscreen Spray SPF50 Z15-034(BAY987516) and Sunscreen Spray SPF50 Z15-038(BAY987516) in people with Sunscreening Agents, run by Bayer at 1 site in United States.
Trial summary
To evaluate the human eye irritation potential of two 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?
- Sunscreen Spray SPF50 Z15-034(BAY987516) and Sunscreen Spray SPF50 Z15-038(BAY987516)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2016to 27 Feb 2016
- 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
- Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
- Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
- Willing to report any medications taken during the study.
- Willing to have the test materials instilled into the eyes and follow all protocol requirements.
- Have been informed and have given written consent to participate in the study.
Who cannot join
- Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
- Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator.
- Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Irritation Potential of Products in Human Eyes
To evaluate the human eye irritation potential of two test sunscreen formulation
- Conditions
- Sunscreening Agents
- Being tested
- Sunscreen Spray SPF50 Z15-034(BAY987516), Shampoo Control, Sunscreen Spray SPF50 Z15-038(BAY987516)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen Spray SPF50 Z15-034(BAY987516)Other
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Shampoo ControlOther
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Sunscreen Spray SPF50 Z15-038(BAY987516)Other
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| Sun Protection Factor (SPF) 50 Z15-034(BAY987516) | Experimental | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. Receives: Other: Sunscreen Spray SPF50 Z15-034(BAY987516); Other: Shampoo Control |
| Sunscreen Spray SPF50 Z15-038(BAY987516) | Experimental | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. Receives: Other: Shampoo Control; Other: Sunscreen Spray SPF50 Z15-038(BAY987516) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of discomfort in the eyes assessed by 5 point scale
Measured: Up to 1 day
Intensity of Lacrimation assessed by 5 grading scale
Measured: Up to 1 day
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale
Measured: Up to 1 day
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start27 Feb 2016
- Primary completion27 Feb 2016
- Study completion27 Feb 2016
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT02728856
- Sponsor's protocol ID
- 18598
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Irritation Potential of Products in Human Eyes
- ClinicalTrials.gov ID
- NCT02728856
- Acronym / sponsor ID
- 18598
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2016 (actual)
- Primary completion
- 27 Feb 2016 (actual)
- Study completion
- 27 Feb 2016 (actual)
- First posted
- 5 Apr 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.
To evaluate the human eye irritation potential of two test sunscreen formulation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sun Protection Factor (SPF) 50 Z15-034(BAY987516) | Experimental | Other: Sunscreen Spray SPF50 Z15-034(BAY987516), Other: Shampoo ControlStudy staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
| Sunscreen Spray SPF50 Z15-038(BAY987516) | Experimental | Other: Shampoo Control, Other: Sunscreen Spray SPF50 Z15-038(BAY987516)Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
- Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
- Willing to report any medications taken during the study.
- Willing to have the test materials instilled into the eyes and follow all protocol requirements.
- Have been informed and have given written consent to participate in the study.
Key exclusion criteria (4 listed)
- Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
- Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator.
- Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
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 |
|---|---|---|
| Sunscreen Spray SPF50 Z15-034(BAY987516)Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. | Other | Sun Protection Factor (SPF) 50 Z15-034(BAY987516) |
| Shampoo ControlStudy staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. | Other | Sun Protection Factor (SPF) 50 Z15-034(BAY987516), Sunscreen Spray SPF50 Z15-038(BAY987516) |
| Sunscreen Spray SPF50 Z15-038(BAY987516)Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. | Other | Sunscreen Spray SPF50 Z15-038(BAY987516) |
Primary outcome
Subjective assessment of discomfort in the eyes assessed by 5 point scale
Time frame: Up to 1 day
Intensity of Lacrimation assessed by 5 grading scale
Time frame: Up to 1 day
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale
Time frame: Up to 1 day
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale
Time frame: Up to 1 day
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 31 Mar 2017.
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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 Sunscreen Spray SPF50 Z15-034(BAY987516) and Sunscreen Spray SPF50 Z15-038(BAY987516) 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 5 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 31 Mar 2017. 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 assessment of discomfort in the eyes assessed by 5 point scale (time frame: Up to 1 day). 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 31 Mar 2017.