Sunscreening AgentsNCT02802917
To Evaluate Eye Installation-Tear Free
A study testing SPF 50 Y49 091 (BAY 987516), SPF 50 X15 158 (BAY 987516) and SPF 50 X15 160 (BAY 987516) in people with Sunscreening Agents, run by Bayer at 1 site in United States.
Trial summary
The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture. 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?
- SPF 50 Y49 091 (BAY 987516), SPF 50 X15 158 (BAY 987516) and SPF 50 X15 160 (BAY 987516)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2015to 24 May 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
- Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
- Subjects not under any doctor's care for ocular or peri orbital diseases
- The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Stinging Potential of Products in Human Eyes
The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.
- Conditions
- Sunscreening Agents
- Being tested
- SPF 50 Y49 091 (BAY 987516), SPF 50 X15 158 (BAY 987516), SPF 50 X15 160 (BAY 987516), SPF 50 X57 162 (BAY 987516), J & J baby shampoo, X46 046 (control)
- Keywords
- Eye stinging potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPF 50 Y49 091 (BAY 987516)Drug
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
SPF 50 X15 158 (BAY 987516)Drug
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
SPF 50 X15 160 (BAY 987516)Drug
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
SPF 50 X57 162 (BAY 987516)Drug
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
J & J baby shampoo, X46 046 (control)Other
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
| Study group | Role | What they receive |
|---|---|---|
| SPF 50 Y49 091 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. Receives: Drug: SPF 50 Y49 091 (BAY 987516); Other: J & J baby shampoo, X46 046 (control) |
| SPF 50 X15 158 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. Receives: Drug: SPF 50 X15 158 (BAY 987516); Other: J & J baby shampoo, X46 046 (control) |
| SPF 50 X15 160 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. Receives: Drug: SPF 50 X15 160 (BAY 987516); Other: J & J baby shampoo, X46 046 (control) |
| SPF 50 X57 162 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. Receives: Drug: SPF 50 X57 162 (BAY 987516); Other: J & J baby shampoo, X46 046 (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective discomfort
Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article
Measured: up to 10 days
Objective lacrimation
Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow
Measured: up to 10 days
Objective conjunctival inflammation
Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids
Measured: up to 10 days
Objective cornea and iris inflammation
Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start15 May 2015
- Primary completion24 May 2015
- Study completion24 May 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 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
- NCT02802917
- Sponsor's protocol ID
- 18271
- Status last verified
- Dec 2018
- First submitted
- 14 Jun 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 of Products in Human Eyes
- ClinicalTrials.gov ID
- NCT02802917
- Acronym / sponsor ID
- 18271
- Conditions
- Sunscreening Agents
- Keywords
- Eye stinging potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2015 (actual)
- Primary completion
- 24 May 2015 (actual)
- Study completion
- 24 May 2015 (actual)
- First posted
- 16 Jun 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 primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPF 50 Y49 091 | Experimental | Drug: SPF 50 Y49 091 (BAY 987516), Other: J & J baby shampoo, X46 046 (control)Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
| SPF 50 X15 158 | Experimental | Drug: SPF 50 X15 158 (BAY 987516), Other: J & J baby shampoo, X46 046 (control)Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
| SPF 50 X15 160 | Experimental | Drug: SPF 50 X15 160 (BAY 987516), Other: J & J baby shampoo, X46 046 (control)Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
| SPF 50 X57 162 | Experimental | Drug: SPF 50 X57 162 (BAY 987516), Other: J & J baby shampoo, X46 046 (control)Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
- Subjects not under any doctor's care for ocular or peri orbital diseases
- The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during 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 |
|---|---|---|
| SPF 50 Y49 091 (BAY 987516)5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. | Drug | SPF 50 Y49 091 |
| SPF 50 X15 158 (BAY 987516)5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. | Drug | SPF 50 X15 158 |
| SPF 50 X15 160 (BAY 987516)5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. | Drug | SPF 50 X15 160 |
| SPF 50 X57 162 (BAY 987516)5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. | Drug | SPF 50 X57 162 |
| J & J baby shampoo, X46 046 (control)5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. | Other | SPF 50 X15 158, SPF 50 X15 160, SPF 50 X57 162, SPF 50 Y49 091 |
Primary outcome
Subjective discomfort
Time frame: up to 10 days
Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article
Objective lacrimation
Time frame: up to 10 days
Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow
Objective conjunctival inflammation
Time frame: up to 10 days
Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids
Objective cornea and iris inflammation
Time frame: up to 10 days
Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris
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
RecruitingPhase 4
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
Epidermis, Ultraviolet Exposure
Recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
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 SPF 50 Y49 091 (BAY 987516), SPF 50 X15 158 (BAY 987516) and SPF 50 X15 160 (BAY 987516) 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 3 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 (time frame: up to 10 days). 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.