Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome

Inclusion criteria

• Patients (male or female) ≥ 18 years of age.
• Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
• Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0).
• Have all the following in the same eye at Visit 0:

• Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3
• Average Tear Film Break up Time ≤ 5 seconds
• Schirmer Test (without anesthesia) ≥ 1 and < 10mm
• Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.

Exclusion criteria

• Comorbidity with other severe or chronic conditions that in the judgment of the investigator will interfere with study assessment, such as such as glaucoma, active neuronal trigeminal disease, neuralgia.
• Best corrected visual acuity (BCVA) baseline <20/200.
• Condition or history other than ocular that, in the opinion of the investigator, may interfere significantly with the patient's participation in the study, such as dementia, psychosis, Parkinson's disease (interference).
• Patient using a contact ocular lens within 7 days prior to administration of the first dose and not willing to cease using them during all study duration.
• Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit.
• Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable non-hormonal contraceptive precautions can be included (See Note A).
• Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study.
• A known adverse reaction and/or sensitivity to the study drug or its components.
• Use of topical ocular cyclosporine, corticosteroids or any other topical anti-inflammatory treatments within 15 days prior to Visit 0 and during all study duration.
• Routine use (more than twice a week) of a chlorinated swimming pool during the study period
• Unwilling or unable to cease using during the study period the forbidden medications:

• Any topical ocular ointments or gels
• Topical and systemic glaucoma therapies
• Systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline)
• Lipidic artificial tears and artificial tears with preservative.
• Unwilling to cease the use of sunscreen on the forehead or eye area during the study period.
• Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day.
• Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.