To Evaluate Eye Installation-Tear Free

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: SPF 50 X15 160 (BAY 987516); Drug: SPF 50 X15 158 (BAY 987516); Drug: SPF 50 X57 162 (BAY 987516); Other: J & J baby shampoo, X46 046 (control); Drug: SPF 50 Y49 091 (BAY 987516)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02802917

18271

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 4 patient groups

SPF 50 Y49 091

Experimental group

Description:

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.

Treatment:

Other: J & J baby shampoo, X46 046 (control)

Drug: SPF 50 Y49 091 (BAY 987516)

SPF 50 X15 158

Experimental group

Description:

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.

Treatment:

Drug: SPF 50 X15 158 (BAY 987516)

Other: J & J baby shampoo, X46 046 (control)

SPF 50 X15 160

Experimental group

Description:

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.

Treatment:

Drug: SPF 50 X15 160 (BAY 987516)

Other: J & J baby shampoo, X46 046 (control)

SPF 50 X57 162

Experimental group

Description:

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.

Treatment:

Drug: SPF 50 X57 162 (BAY 987516)

Other: J & J baby shampoo, X46 046 (control)