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

NCT04645446 | Completed Phase 2

• 2 other identifiers: 049/SI2019-000747-27
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Corneal Fluorescein Staining

  Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

  Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

• SANDE questionnaire

  Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84) (with LOCF imputation)

  Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

Secondary Outcomes (16)

• Corneal fluorescein staining

  Week 12 (Day 84)

• SANDE questionnaire

  Week 12 (Day 84)

• Conjunctival fluorescein staining

  Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

• Conjunctival fluorescein staining

  Week 12 (Day 84)

• Corneal fluorescein staining

  Week 2, 4, 8 (Day 14, 28, 56)

Study Arms (3)

Pro-ocular™ 1% Progesterone EP topical gel

EXPERIMENTAL

Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.7 mg of progesterone

Drug: Pro-ocular gel

Pro-ocular™ 0.5% Progesterone EP topical gel

EXPERIMENTAL

Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.35 mg of progesterone

Drug: Pro-ocular gel

Placebo topical gel

PLACEBO COMPARATOR

Multidose formulation identical in appearance to Experimental Products despensing unit doses of 0.07 g of topical gel containing 0 mg of progesterone

Drug: Placebo gel

Interventions

Pro-ocular gel DRUG

Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Pro-ocular™ 0.5% Progesterone EP topical gel; Pro-ocular™ 1% Progesterone EP topical gel

Placebo gel DRUG

Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Placebo topical gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (4)

Ospedale San Marco - Azienda Ospedaliera Universitaria

Catania, 95121,, Italy

Location

A.O.U. Careggi Firenze - SOD Oculistica

Florence, 50134, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia

Messina, 98125, Italy

Location

Ospedale Luigi Sacco Polo Universitario - Oculistica

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation Ratio = 1:1:1

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 27, 2020
• Study Start: February 18, 2021
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: December 23, 2022

Record last verified: 2021-03

Locations

IT (4)