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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 (ProGIFT)

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ClinicalTrials.gov Identifier: NCT04645446
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
SIFI SpA

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.


Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Pro-ocular gel Drug: Placebo gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation Ratio = 1:1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Pro-ocular™ 1% Progesterone EP topical gel
Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.7 mg of progesterone
Drug: Pro-ocular gel
Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Experimental: Pro-ocular™ 0.5% Progesterone EP topical gel
Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.35 mg of progesterone
Drug: Pro-ocular gel
Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

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




Primary Outcome Measures :
  1. Corneal Fluorescein Staining [ Time Frame: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation) ]
    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)

  2. SANDE questionnaire [ Time Frame: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation) ]
    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)


Secondary Outcome Measures :
  1. Corneal fluorescein staining [ Time Frame: Week 12 (Day 84) ]
    Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 12 (Day 84).

  2. SANDE questionnaire [ Time Frame: Week 12 (Day 84) ]
    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).

  3. Conjunctival fluorescein staining [ Time Frame: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation) ]
    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with LOCF imputation).

  4. Conjunctival fluorescein staining [ Time Frame: Week 12 (Day 84) ]
    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84).

  5. Corneal fluorescein staining [ Time Frame: Week 2, 4, 8 (Day 14, 28, 56) ]
    Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.

  6. SANDE questionnaire [ Time Frame: Week 2, 4, 8, 16 (Day 14, 28, 56,114) ]
    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 2, 4, 8, 16 (Day 14, 28, 56,114) as intermediate study visits.

  7. Conjunctival fluorescein staining [ Time Frame: Week 2, 4, 8 (Day 14, 28, 56) ]
    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.

  8. Non-Invasive Keratograph Tear Film Break Up (NIKBUT) Time (NIKBUT) [ Time Frame: Week 2, 4, 8, 12 (Day 14, 28, 56, 84) ]
    Mean change from baseline (Visit 1 pre-dose) in Non-Invasive Keratograph Tear Film Break Up Time (NIKBUT) at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

  9. Fluorescein Tear Film Break Up Time (TBUT) [ Time Frame: Week 12 (Day 84) ]
    Mean change from baseline (Visit 1 pre-dose) in Fluorescein Tear Film Break Up Time (TBUT) at Week 12 (Day 84).

  10. Tear meniscus height (TMH) [ Time Frame: Week 2, 4, 8, 12 (Day 14, 28, 56, 84)] ]
    Mean change from baseline (Visit 1 pre-dose) in Tear meniscus height (TMH) at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

  11. Schirmer test [ Time Frame: Week 4 (Day 28) and Week 12 (Day 84) ]
    Mean change from baseline (Visit 0 Screening) in Schirmer test at Week 4 (Day 28) and at Week 12 (Day 84).

  12. Dry Eye-Related Quality-of-Life (DEQS) questionnaire [ Time Frame: Each applicable post baseline visit ]
    Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life (DEQS) questionnaire.

  13. Visual Analogue Scale [ Time Frame: Each applicable post baseline visit ]
    Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.

  14. Visual Analogue Scale [ Time Frame: Week 2, 4, 8, 12 (Day 14, 28, 56, 84) ]
    Mean change from baseline (Visit 1 pre-dose) in Visual Analogue Scale 7 symptoms items to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

  15. Corneal Sensitivity [ Time Frame: Week 4, 12 (Day 28, 84) ]
    Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable postbaseline visit [Week 4, 12 (Day 28, 84)].

  16. Slit Lamp Examination [ Time Frame: Week 2, 4, 8, 12 (Day 14, 28, 56, 84) ]
    Mean change from baseline (Visit 0 Screening) in Slit Lamp Examination to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645446


Contacts
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Contact: Gianluca Stivale +39 3356070038 gianluca.stivale@sifigroup.com
Contact: Sebastiano Giuffrida +39 3357615356 sebastiano.giuffrida@sifigroup.com

Locations
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Italy
Ospedale San Marco - Azienda Ospedaliera Universitaria Recruiting
Catania, Italy, 95121,
Contact: Caterina Gagliano, MD    +39 3472698035    caterina_gagliano@hotmail.com   
A.O.U. Careggi Firenze - SOD Oculistica Recruiting
Florence, Italy, 50134
Contact: Rita Mencucci, MD    +39 3356274390    rita.mencucci@unifi.it   
Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia Recruiting
Messina, Italy, 98125
Contact: Pasquale Aragona, MD    +39.3483384677    paragona@unime.it   
Ospedale Luigi Sacco Polo Universitario - Oculistica Recruiting
Milan, Italy, 20157
Contact: Stefano Barabino, MD, PhD    +39 3395480804    sbarabi@tin.it   
Sponsors and Collaborators
SIFI SpA
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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT04645446    
Other Study ID Numbers: 049/SI
2019-000747-27 ( EudraCT Number )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases