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Evaluation of the Performance of MAF-1217 on Cataract Surgery

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MAF-1217
Sponsored by
VISUfarma SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Università di Firenze, Clinica Oculistica II,
  • Ospedale San Paolo, ASST Santi Paolo e Carlo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patients receiving MAF-1217

patients receiving just standard antibiotic therapy

Arm 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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2019
Last Updated
July 12, 2019
Sponsor
VISUfarma SpA
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1. Study Identification

Unique Protocol Identification Number
NCT03833908
Brief Title
Evaluation of the Performance of MAF-1217 on Cataract Surgery
Official Title
Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VISUfarma SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients receiving MAF-1217
Arm Type
Experimental
Arm 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.
Arm Title
patients receiving just standard antibiotic therapy
Arm Type
No Intervention
Arm 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).
Intervention Type
Device
Intervention Name(s)
MAF-1217
Intervention Description
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
Primary Outcome Measure Information:
Title
break-up time (BUT)
Description
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 Outcome Measure Information:
Title
osmolarity
Description
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity
Time Frame
1 month
Title
OSDI score
Description
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
Title
Schirmer test I
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Inability to self-administer study medications Known allergic sensitivity to any of the devices ingredients, or any other type of allergy Participation in a clinical trial during the 3 months prior to the beginning of the study
Facility Information:
Facility Name
Università di Firenze, Clinica Oculistica II,
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale San Paolo, ASST Santi Paolo e Carlo
City
Milan
ZIP/Postal Code
20121
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32185729
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of the Performance of MAF-1217 on Cataract Surgery

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