A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Ophthalmic Solutions

Treatments: Drug: F# 13418-148 Eye Drops; Drug: F#13418-158 Eye Drops; Drug: F# PF-004390 Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198000

CO-161103095739-VCCT

Details and patient eligibility

About

This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Full description

Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
3. Male or female of any race or ethnicity, aged 18 years and older;
4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
5. Able to read and understand English;
6. Healthy subjects with redness in both eyes
7. History of topical ocular drugs or desire to use within the last 6 months;
8. Ocular health within normal limits,
9. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

Exclusion criteria

1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
2. Known sensitivity, allergy or contraindications to any investigational product ingredient;
3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;
4. Subjects who were previously screened and determined to be ineligible for the study;
5. Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
7. Relative, partner or staff of any clinical research site personnel;
8. Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
11. Has a compromised immune system;
12. Has any acute or chronic, medical or psychiatric conditions
13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Formula # 13418-148

Experimental group

Treatment:

Drug: F# 13418-148 Eye Drops

Formula # 13418-158

Experimental group

Treatment:

Drug: F#13418-158 Eye Drops

Control Formula # PF004390

Active Comparator group

Treatment:

Drug: F# PF-004390 Eye Drops