Evaluation of the Performance of MAF-1217 on Cataract Surgery

VISUfarma

Status: Completed

Conditions: Dry Eye

Treatments: Device: MAF-1217

Study type: Interventional

Funder types: Industry

Identifiers

NCT03833908

VF-OS-002/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

patients receiving MAF-1217

Experimental group

Description:

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.

Treatment:

Device: MAF-1217

patients receiving just standard antibiotic therapy

No Intervention group

Description:

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).