To Evaluate Eye Installation-Tear Free

NCT02802917 | Completed

• 1 other identifier: 18271
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sunscreening Agents

Keywords

Eye stinging potential

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  up to 10 days

Study Arms (4)

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.

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.

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.

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.

Drug: SPF 50 X57 162 (BAY 987516); Other: J & J baby shampoo, X46 046 (control)

Interventions

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 Y49 091

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 158

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 X15 160

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.

SPF 50 X57 162

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.

SPF 50 X15 158; SPF 50 X15 160; SPF 50 X57 162; SPF 50 Y49 091

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: May 15, 2015
• Primary Completion: May 24, 2015
• Study Completion: May 24, 2015
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)