Status:
UNKNOWN
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
Lead Sponsor:
VISUfarma SpA
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate ...
Detailed Description
The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator. Patients, after signing the Informed Consent, will enter into a 1-week screening phase during w...
Eligibility Criteria
Inclusion
- Patient Informed consent form (ICF) signed.
- Males and Females aged ≥18 years at the time of the signature of ICF.
- Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment.
- No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions.
- TBUT value \<6 sec.
- Willing to follow all study procedures, including attending all site visits, tests and examinations.
- Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.
Exclusion
- Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively).
- Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment.
- No previous history or presence of any disease involving cornea or conjunctiva.
- Sjӧgren syndrome.
- History or active cicatricial conjunctivitis.
- History of ocular surface burns.
- Use of contact lenses.
- Corneal refractive surgery 1 year post-operative.
- Any ocular surgery in the previous 3 months preceding the study.
- Unstable glaucoma (treatment changes in the last year).
- Any macular or retinal disease that could impact visual acuity.
- Best corrected visual acuity (BCVA) below 20/40.
- Blepharitis treatment started less than 3 months before enrolment.
- Neurological, neurodegenerative or cerebrovascular conditions.
- Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.
- Unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers.
- Known hypersensitivity to one of the administered products.
- Known drug and/or alcohol abuse.
- Mental incapacity that precludes adequate understanding or cooperation.
- Participation in another investigational study or blood donation within 1 month prior to ICF signature.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04485533
Start Date
July 6 2020
End Date
April 30 2021
Last Update
July 24 2020
Active Locations (3)
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1
Hôpital Morvan
Brest, Finistère, France, 29200
2
ASST-Santi Paolo e Carlo-Presidio San Paolo
Milan, MI, Italy, 20142
3
Hospital Clínico San Carlos de Madrid
Madrid, Spain, 28040