Evaluation of the Performance of MAF-1217 on Cataract Surgery

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Device: MAF-1217

• Registration Number: NCT03833908
• Lead Sponsor: VISUfarma SpA

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.

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-07
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients receiving MAF-1217	MAF-1217	patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery.

Primary Outcome Measures

Name	Time	Method
break-up time (BUT)	1 month	Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)

Secondary Outcome Measures

Name	Time	Method
Schirmer test I	1 month	Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears)
OSDI score	1 month	Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score.; The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
osmolarity	1 month	Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity

Trial Locations

Locations (2)

Università di Firenze, Clinica Oculistica II,; 🇮🇹 Firenze, Italy

Ospedale San Paolo, ASST Santi Paolo e Carlo; 🇮🇹 Milan, Italy