Status:
COMPLETED
Evaluation of the Performance of MAF-1217 on Cataract Surgery
Lead Sponsor:
VISUfarma SpA
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symp...
Detailed Description
This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED ...
Eligibility Criteria
Inclusion
- At least 18 years old patients, male and female
- Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT \>7
- Normal to mild DED according to OSDI chart
- Diagnosis of Cataract requiring surgery
- Wishing to participate in the study and able to sign the ICF
- Shirmer test \> 15 mm /5'
- No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
Exclusion
- Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
- Patients with diagnosis of Glaucoma
- Functional and anatomic eyelid abnormalities,
- Complicated cataract,
- Suture affixing during surgery,
- Use of artificial tears in the month preceding the study visit
- Coexisting corneal diseases
- Autoimmune diseases
- Past or active cicatricial conjunctivitis
- Past ocular surface burns
- Keratinization of the eyelid margin
- Sjogren syndrome
- History of corneal trauma
- Pregnant and lactating women
- Younger than 18 years old patients
- Inability to self-administer study medications
- Known allergic sensitivity to any of the devices ingredients, or any other type of allergy
- Participation in a clinical trial during the 3 months prior to the beginning of the study
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03833908
Start Date
November 20 2018
End Date
June 17 2019
Last Update
July 15 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Università di Firenze, Clinica Oculistica II,
Florence, Italy, 50134
2
Ospedale San Paolo, ASST Santi Paolo e Carlo
Milan, Italy, 20121