NCT03833908

Evaluation of the Performance of MAF-1217 on Cataract Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	MAF-1217	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

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-06-17
• Completion: 2019-06-17
• First posted: 2019-02-07
• Last updated: 2019-07-15

Locations

2 sites across 1 country: Italy