Evaluation of the Performance of MAF-1217 on Cataract Surgery

VISUfarma SpA46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye

Interventions

MAF-1217DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Università di Firenze, Clinica Oculistica II,

Florence, Italy

Ospedale San Paolo, ASST Santi Paolo e Carlo

Milan, Italy

Outcomes

Primary Outcomes

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)

Time frame: 1 month

Secondary Outcomes

osmolarity

Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity

Time frame: 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.

Time frame: 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)

Time frame: 1 month

Data from ClinicalTrials.gov

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