A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Completed · Phase 3

Conditions studied: Ophthalmic Solutions

In brief

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.

Key facts

Study ID

NCT03198000

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

120

Starts

2017-06-28

Expected to finish

2017-07-21

Last updated by the study team

2023-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;
• Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
• Male or female of any race or ethnicity, aged 18 years and older;
• Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
• Able to read and understand English;
• Healthy subjects with redness in both eyes
• History of topical ocular drugs or desire to use within the last 6 months;
• Ocular health within normal limits,
• 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.

You may not qualify if…

• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
• Known sensitivity, allergy or contraindications to any investigational product ingredient;
• Females who are pregnant, planning to become pregnant or breastfeeding during the study;
• Subjects who were previously screened and determined to be ineligible for the study;
• 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;
• Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
• Relative, partner or staff of any clinical research site personnel;
• 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;
• Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
• Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
• Has a compromised immune system;
• Has any acute or chronic, medical or psychiatric conditions
• Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
• Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
• Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Where it is running

• Andover Eye Associates — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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