Evaluation of the Performance of MAF-1217 on Cataract Surgery

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833908
• Other study ID #: VF-OS-002/2018
• Status: Completed
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: July 2019
• Source: VISUfarma SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Dry Eye

Intervention

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

Locations

Country	Name	City	State
Italy	Università di Firenze, Clinica Oculistica II,	Firenze
Italy	Ospedale San Paolo, ASST Santi Paolo e Carlo	Milan

Sponsors (1)

Lead Sponsor	Collaborator
VISUfarma SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	osmolarity	Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity	1 month
Secondary	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
Secondary	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