Evaluation of the Performance of MAF-1217 on Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery

Conditions
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Dry Eye

Intervention / Treatment
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* Device: MAF-1217


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients receiving MAF-1217<br>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. | Device: MAF-1217<br>* 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<br>|
| No Intervention: patients receiving just standard antibiotic therapy<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |