A clinical trial to evaluate the Safety and Efficacy of Pro-ocular™ topical gel in two different concentration, 0.5% and 1%, when administered in the forehead twice a day for 12 weeks in Patients diagnosed with Dry Eye Syndrome.
- Conditions
- Dry Eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which tear film instability, hyperosmolarity, ocular surface inflammation and damage, neurosensory abnormalities play an etiological role. Patient-reported symptoms for DE include dryness, grittiness, itching, redness, fluctuating visual disturbances and ocular fatigue.MedDRA version: 21.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-000747-27-IT
- Lead Sponsor
- SOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 105
- Patients (male or female) must be >= 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
- Comorbidity with other severe or chronic eye 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
- 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
- Unwilling to cease the use of sunscreen on the forehead or eye area during the study period
- Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method