Effects of NOV03 on the Tear Film

Exclusion Criteria

• •1. Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including
• •1. history of eye trauma
• •2. history of Stevens-Johnson syndrome
• •3. active blepharitis or lid margin inflammation
• •4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
• •5. abnormal lid anatomy that caused incomplete eyelid closure
• •6. abnormal cornea shape (keratoconus)
• •7. corneal epithelial defect or significant confluent staining or filaments
• •8. history of herpetic keratitis.
• •9. has a pterygium in either eye.
• •10. ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial
• •2. Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit 1.
• •3. Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 2.
• •4. Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2.
• •5. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2.
• •6. Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
• •7. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial.
• •8. Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period.
• •9. Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
• •10. Is a woman who was pregnant, nursing or planning a pregnancy.
• •11. Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: 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 could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
• •12. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial.
• •13. Has a known allergy and/or sensitivity to the investigational drug.
• •14. Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial.
• •15. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1.
• •16. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit 1.
• •17. Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.