A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

Who cannot join

• 1. Have any clinically significant slit lamp findings at Visit l that may include active blepharitis, meibomian gland dysfunction, severe lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Note: Patients with moderate to severe meibomian gland dysfunction, in the opinion of the investigator, will not be eligible to participate in the study.
• 2. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit l; 3. Have worn contact lenses within 7 days of Visit l or anticipate using contact lenses during the study; 4. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last l2 months; 5. Have used Restasis®, Xiidra®, Cequa®, Eysuvis®, or Tyrvaya®, Vevye® within 45 days of Visit l; 6. Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period; 7. Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit l; 8. Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash-out periods are required for the following medications: Confidential 6
• Antihistamines (including ocular): 72 hours prior to Visit 1
• Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
• Corticosteroids or mast cell stabilizers (including ocular): l4 days prior to Visit 1
• Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
• All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1 9. Have an uncontrolled systemic disease 10. Be a woman who is pregnant, nursing, or planning a pregnancy; 11. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is post- menopausal (without menses for l2 consecutive months); 12. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study; 13. Have a known allergy and/or sensitivity to the test article or its components; 14. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; 15. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1; 16. Be unable or unwilling to follow instructions, including participation in all study assessments and visits.