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
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Pro-ocular gelDrug: Placebo gel
- Registration Number
- NCT04645446
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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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:
- 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
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Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.
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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:
- 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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pro-ocular™ 0.5% Progesterone EP topical gel Pro-ocular gel Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.35 mg of progesterone Placebo topical gel Placebo gel Multidose formulation identical in appearance to Experimental Products despensing unit doses of 0.07 g of topical gel containing 0 mg of progesterone Pro-ocular™ 1% Progesterone EP topical gel Pro-ocular gel Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.7 mg of progesterone
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\].
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.
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.
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).
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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\].
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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\].
Corneal Sensitivity Week 4, 12 (Day 28, 84) Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable postbaseline visit \[Week 4, 12 (Day 28, 84)\].
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.
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).
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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\].
Trial Locations
- Locations (4)
A.O.U. Careggi Firenze - SOD Oculistica
🇮🇹Florence, Italy
Ospedale Luigi Sacco Polo Universitario - Oculistica
🇮🇹Milan, Italy
Ospedale San Marco - Azienda Ospedaliera Universitaria
🇮🇹Catania, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia
🇮🇹Messina, Italy