NCT03833908

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

January 31, 2019

Last Update Submit

July 12, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • osmolarity

    1 month

  • OSDI score

    1 month

  • Schirmer test I

    1 month

Study Arms (2)

patients receiving MAF-1217

EXPERIMENTAL

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

patients receiving just standard antibiotic therapy

NO INTERVENTION

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).

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

patients receiving MAF-1217

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Università di Firenze, Clinica Oculistica II,

Florence, 50134, Italy

Location

Ospedale San Paolo, ASST Santi Paolo e Carlo

Milan, 20121, Italy

Location

Related Publications (1)

  • Fogagnolo P, Favuzza E, Marchina D, Cennamo M, Vignapiano R, Quisisana C, Rossetti L, Mencucci R. New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study. Adv Ther. 2020 Apr;37(4):1664-1674. doi: 10.1007/s12325-020-01288-z. Epub 2020 Mar 17.

    PMID: 32185729DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 7, 2019

Study Start

November 20, 2018

Primary Completion

June 17, 2019

Study Completion

June 17, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

IT(2)