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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving MAF-1217 | Experimental | 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. |
|
| patients receiving just standard antibiotic therapy | No Intervention | patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAF-1217 | Device | Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| break-up time (BUT) | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| osmolarity | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity | 1 month |
| OSDI score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università di Firenze, Clinica Oculistica II, | Florence | 50134 | Italy | |||
| Ospedale San Paolo, ASST Santi Paolo e Carlo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32185729 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 1 month |
| Schirmer test I | 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) | 1 month |
| Milan |
| 20121 |
| Italy |