ProGIFT: 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
Study Details
Study Description
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
|
Outcome Measures
Primary Outcome Measures
- Corneal Fluorescein Staining [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)
- SANDE questionnaire [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
- Corneal fluorescein staining [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).
- SANDE questionnaire [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).
- Conjunctival fluorescein staining [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).
- Conjunctival fluorescein staining [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).
- Corneal fluorescein staining [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.
- SANDE questionnaire [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.
- Conjunctival fluorescein staining [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.
- Non-Invasive Keratograph Tear Film Break Up (NIKBUT) Time (NIKBUT) [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)].
- Fluorescein Tear Film Break Up Time (TBUT) [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).
- Tear meniscus height (TMH) [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)].
- Schirmer test [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).
- Dry Eye-Related Quality-of-Life (DEQS) questionnaire [Each applicable post baseline visit]
Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life (DEQS) questionnaire.
- Visual Analogue Scale [Each applicable post baseline visit]
Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.
- Visual Analogue Scale [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)].
- Corneal Sensitivity [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)].
- Slit Lamp Examination [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)].
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients (male or female) ≥ 18 years of age.
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Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
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Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0).
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Have all the following in the same eye at Visit 0:
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Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3
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Average Tear Film Break up Time ≤ 5 seconds
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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:
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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.
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Best corrected visual acuity (BCVA) baseline <20/200.
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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).
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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.
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Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit.
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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).
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Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study.
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A known adverse reaction and/or sensitivity to the study drug or its components.
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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.
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Routine use (more than twice a week) of a chlorinated swimming pool during the study period
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Unwilling or unable to cease using during the study period the forbidden medications:
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Any topical ocular ointments or gels
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Topical and systemic glaucoma therapies
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Systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline)
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Lipidic artificial tears and artificial tears with preservative.
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Unwilling to cease the use of sunscreen on the forehead or eye area during the study period.
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Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day.
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Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ospedale San Marco - Azienda Ospedaliera Universitaria | Catania | Italy | 95121, | |
2 | A.O.U. Careggi Firenze - SOD Oculistica | Florence | Italy | 50134 | |
3 | Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia | Messina | Italy | 98125 | |
4 | Ospedale Luigi Sacco Polo Universitario - Oculistica | Milan | Italy | 20157 |
Sponsors and Collaborators
- SIFI SpA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 049/SI
- 2019-000747-27