| Eligibility |
Inclusion Criteria:
1. Be at least 18 years of age at the time of Informed Consent signing of either gender
and any race or ethnicity;
2. Provide written informed consent and sign the HIPAA form;
3. Be willing and able to follow all instructions and attend all study visits;
4. Have a history of vasoconstrictor (redness relief drops) use within the last 6 months,
or a desire to use OTC vasoconstrictors for redness relief;
5. Be able to self-administer eye drops satisfactorily or have a subject's care provider
at home1 routinely available for this purpose;
6. (If female and of childbearing potential) agree to have urine pregnancy testing
performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and
must agree to use at least 1 medically acceptable form of birth control2 throughout
the study duration and for at least 14 days prior to the first dose of study drug
(Visit 1) and for 1 month after the last dose of investigational drug. Note: Women
considered capable of becoming pregnant include all females who have experienced
menarche and have not experienced menopause (as defined by amenorrhea for greater than
12 consecutive months) and have not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
7. (If male and with female partner of childbearing potential) must use at least 1
medically acceptable form of birth control3;
8. A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better in
each eye, as measured using an ETDRS chart;
9. At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1 unit)
in both eyes on a 0 to 4 unit scale as scored by the Investigator using the
Investigator Ocular Redness Scale;
10. Have stable ocular health (defined as no ocular conditions requiring therapy or
surgical intervention during the study).
Exclusion Criteria:
1. Have known contraindications or sensitivity to the use of any of the investigational
drug(s) or their components, or any other medications required by the protocol;
2. Have had ocular surgical intervention within 3 months prior to screening or during the
study and/or a history of refractive surgery within the past 6 months;
3. Have the presence of an active ocular infection (bacterial, viral, or fungal) or
positive history of an ocular herpetic infection at any visit;
4. Use any of the following disallowed medications during the period indicated prior to
screening and for the duration of the study:
- All topical ophthalmic agents including artificial tear products, eye whiteners
(e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocular
corticosteroids, dilating drops, (excluding dilated ophthalmoscopy exam at Visit
1) and contact lenses: 5 days
- Systemic antihistamines or decongestants: 7 days
- Systemic corticosteroids or cancer chemotherapy, and/or any other systemic
medications which the investigator feels may confound study data, or interfere
with subject's study participation: 14 days
5. Have prior (within 7 days of beginning investigational drug) or currently active
significant illness that could compromise participation, in the opinion of the
investigator;
6. Have prior (within 30 days of beginning investigational drug) or anticipated
concurrent use of an investigational drug or device during the study period;
7. Have an ocular or systemic condition or a situation which, in the investigator's
opinion, may put the subject at increased risk, confound study data, or interfere
significantly with the subject's study participation;
8. Have planned surgery (ocular or systemic) during the trial period or within 30 days
after the study period;
9. Be currently breast feeding or planning to breast feed during the study period or is a
female who is currently pregnant, is planning a pregnancy, or has a positive urine
pregnancy test at Visit 1;
10. Have a diagnosis of ocular hypertension or glaucoma at screening;
11. Have symptoms that, in the opinion of the investigator, may be associated with
COVID-19 or in the last 14 days came into contact with someone diagnosed with
COVID-19.
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