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

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients With Dry Eye Syndrome

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial.

The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.

Inclusion Criteria:

1. Patients (male or female) ≥ 18 years of age.

2. Able and willing to provide voluntary written Informed Consent prior to any study related procedure.

3. Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0).

4. 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

5. Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.

Exclusion Criteria:

1. 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.

2. Best corrected visual acuity (BCVA) baseline <20/200.

3. 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).

4. 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.

5. Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit.

6. 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).

7. Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study.

8. A known adverse reaction and/or sensitivity to the study drug or its components.

9. 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.

10. Routine use (more than twice a week) of a chlorinated swimming pool during the study period

11. 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.

12. Unwilling to cease the use of sunscreen on the forehead or eye area during the study period.

13. Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day.

14. Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.