A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Condition: Ophthalmic Solutions
Intervention: F# 13418-148 Eye Drops; F#13418-158 Eye Drops; F# PF-004390 Eye Drops
Intervention description: ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day; ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day; Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eye Redness; Eye Comfort; Red Eyes

Summary:

      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.
    

Eligibility criteria:

        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.