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Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery

Primary Purpose

Eye Diseases

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Lacrimera

About this trial

This is an interventional supportive care trial for Eye Diseases

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 22 or older
Scheduled for cataract surgery
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Written informed consent prior to surgery

Exclusion Criteria:

Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathology (e.g. corneal scars, etc.)
Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
Previous ocular surgery or trauma in the study eye within 6 months of the cataract surgery
Active ocular infection or inflammation
Pregnancy (pregnancy test will be taken in women of reproductive age)
Subjects with surgery longer than 30 minutes will be excluded and replaced

Sites / Locations

Vienna Institute for Research in Ocular Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

15 patients will be included in group 1 (no additional treatment)

15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)

15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)

Outcomes

Primary Outcome Measures

Difference in National Eye Institute Grading Scale (NEI Score)

Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery

Secondary Outcome Measures

Difference in NEI Score between all visits post-operatively in the different groups

Difference in break-up time and non-invasive break-up time between the groups at all visits

Difference in NEI Score between the groups at all visits

Subjective complaints using OSDI score

Subjective complaints in the 3 groups using OSDI score

Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups

Difference in number of MMP-9 positive eyes

Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups

Subjective complaints using VAS

Subjective complaints in the 3 groups using VAS

Full Information

NCT ID

NCT05064189

First Posted

August 31, 2021

Last Updated

September 21, 2021

Sponsor

Vienna Institute for Research in Ocular Surgery

1. Study Identification

Unique Protocol Identification Number

NCT05064189

Brief Title

Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery

Official Title

Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 14, 2021 (Actual)

Primary Completion Date

September 10, 2021 (Actual)

Study Completion Date

September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to assess if treatment with Lacrimera® eye drops (Croma-Pharma GbmH, Leobendorf, Austria) during and/ or after cataract surgery has a positive effect on the ocular surface compared to control group.

Detailed Description

Prior to surgery, pre-assessment measurements will be performed in the same fashion as for non-study patients. Patients will be randomized to one of the 3 groups in a 1:1:1 fashion using an online randomization tool (www.randomizer.org, list randomizer). Surgery is performed in topical anaesthesia. Right after topical anaesthesia, patients allocated to Group 3 will receive 1 drop of Lacrimera® in the study eye. Injection of viscoelastic substance (OVD), capsulorhexis, phacoemulsification, and coaxial irrigation/ aspiration of cortical material are performed as standard procedure. After IOL implantation the OVD will be removed and at the end of the surgery, stromal hydration will be performed to the incision as a routine procedure to seal the wound. Right after the wound is sealed, patients allocated to group 2 and group 3 will receive 1 drop of Lacrimera® in the study eye. Postoperative standard medication (Bromfenac gtt., twice a day for 4 weeks) will be prescribed for all groups.

6. Conditions and Keywords

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

Eye Diseases

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

No Intervention

Arm Description

15 patients will be included in group 1 (no additional treatment)

Arm Title

Group 2

Arm Type

Experimental

Arm Description

15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)

Arm Title

Group 3

Arm Type

Experimental

Arm Description

15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)

Intervention Type

Device

Intervention Name(s)

Lacrimera

Intervention Description

A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.

Primary Outcome Measure Information:

Title

Difference in National Eye Institute Grading Scale (NEI Score)

Description

Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

Difference in NEI Score between all visits post-operatively in the different groups

Description

Difference in NEI Score between all visits post-operatively in the different groups

Time Frame

7 days +/- 1 day

Title

Difference in break-up time and non-invasive break-up time between the groups at all visits

Description

Difference in break-up time and non-invasive break-up time between the groups at all visits

Time Frame

7 days +/- 1 day

Title

Difference in NEI Score between the groups at all visits

Description

Difference in NEI Score between the groups at all visits

Time Frame

7 days +/- 1 day

Title

Subjective complaints using OSDI score

Description

Subjective complaints in the 3 groups using OSDI score

Time Frame

7 days +/- 1 day

Title

Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups

Description

Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups

Time Frame

7 days +/- 1 day

Title

Difference in number of MMP-9 positive eyes

Description

Difference in number of MMP-9 positive eyes before surgery and 1 week after surgery in the different groups

Time Frame

7 days +/- 1 day

Title

Subjective complaints using VAS

Description

Subjective complaints in the 3 groups using VAS

Time Frame

7 days +/- 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 22 or older Scheduled for cataract surgery Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Written informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathology (e.g. corneal scars, etc.) Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A) Previous ocular surgery or trauma in the study eye within 6 months of the cataract surgery Active ocular infection or inflammation Pregnancy (pregnancy test will be taken in women of reproductive age) Subjects with surgery longer than 30 minutes will be excluded and replaced

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Findl, PrimUnivPrDr

Organizational Affiliation

Vienna Institute for Research in Ocular Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vienna Institute for Research in Ocular Surgery

City

Vienna

ZIP/Postal Code

1140

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery

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