Dry Eye Disease
Conditions
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.
Interventions
DRUGPro-ocular gel
Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months
DRUGPlacebo gel
Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months
Sponsors
SIFI SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Allocation Ratio = 1:1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\]. |
| 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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\]. |
| 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). |
| 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. |
| 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 \[Week 2, 4, 8, 12 (Day 14, 28, 56, 84)\]. |
| 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). |
| 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). |
Countries
Italy
Outcome results
None listed