Effects of NOV03 on the Tear Film

Inclusion criteria

General/Ocular Inclusion Criteria

• Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) ≤5 sec at Visit

• Have Ocular Surface Disease Index (OSDI) ≥25 at Visit 1.
• Have an unanesthetized Schirmer's Test I ≥5 mm at Visit 1.
• Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1.
• Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1.
• Have at least one eye that satisfies all criteria for 4-8 above at Visit 1.
• Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus
• Is able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion criteria

General/Ocular Exclusion Criteria

• 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

• history of eye trauma
• history of Stevens-Johnson syndrome
• active blepharitis or lid margin inflammation
• DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
• abnormal lid anatomy that caused incomplete eyelid closure
• abnormal cornea shape (keratoconus)
• corneal epithelial defect or significant confluent staining or filaments
• history of herpetic keratitis.
• has a pterygium in either eye.
• ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial
• 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.
• 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.
• Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2.
• Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2.
• Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
• Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial.
• 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.
• Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
• Is a woman who was pregnant, nursing or planning a pregnancy.
• 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.
• Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial.
• Has a known allergy and/or sensitivity to the investigational drug.
• 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.
• Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1.
• 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.
• Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.