A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye

CO-161103095739-VCCT

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.

2017-06-28

2017-07-21

2017-07-21

Completed

Early phase I

120

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.

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2023-05-24