Clinical trial NCT03833908: Evaluation of the Performance of MAF-1217 on Cataract Surgery
Official title: Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
First posted: 2019-02-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.

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 in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years old patients, male and female
2. Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT \>7
3. Normal to mild DED according to OSDI chart
4. Diagnosis of Cataract requiring surgery
5. Wishing to participate in the study and able to sign the ICF
6. Shirmer test \> 15 mm /5'
7. No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion Criteria:

1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
2. Patients with diagnosis of Glaucoma
3. Functional and anatomic eyelid abnormalities,
4. Complicated cataract,
5. Suture affixing during surgery,
6. Use of artificial tears in the month preceding the study visit
7. Coexisting corneal diseases
8. Autoimmune diseases
9. Past or active cicatricial conjunctivitis
10. Past ocular surface burns
11. Keratinization of the eyelid margin
12. Sjogren syndrome
13. History of corneal trauma
14. Pregnant and lactating women
15. Younger than 18 years old patients
16. Inability to self-administer study medications
17. Known allergic sensitivity to any of the devices ingredients, or any other type of allergy
18. Participation in a clinical trial during the 3 months prior to the beginning of the study

Primary outcomes:
measure: break-up time (BUT)
timeFrame: 1 month
Secondary outcomes:
measure: osmolarity
timeFrame: 1 month
measure: OSDI score
timeFrame: 1 month
measure: Schirmer test I
timeFrame: 1 month
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Università di Firenze, Clinica Oculistica II,
city: Milan
country: Italy
facility: Ospedale San Paolo, ASST Santi Paolo e Carlo
Study officials:
References:
citation: Fogagnolo P, Favuzza E, Marchina D, Cennamo M, Vignapiano R, Quisisana C, Rossetti L, Mencucci R. New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study. Adv Ther. 2020 Apr;37(4):1664-1674. doi: 10.1007/s12325-020-01288-z. Epub 2020 Mar 17.