Eye DiseasesNCT05064189
Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery
A study testing Lacrimera in people with Eye Diseases, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Lacrimera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 14 Apr 2021to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study
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.
Read the 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.
- Conditions
- Eye Diseases
- Being tested
- Lacrimera
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacrimeraDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | 15 patients will be included in group 1 (no additional treatment) |
| Group 2 | Experimental | 15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre) Receives: Device: Lacrimera |
| Group 3 | Experimental | 15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3) Receives: Device: Lacrimera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (7)
Difference in NEI Score between all visits post-operatively in the different groups
Difference in NEI Score between all visits post-operatively in the different groups
Measured: 7 days +/- 1 day
Difference in break-up time and non-invasive break-up time between the groups at all visits
Difference in break-up time and non-invasive break-up time between the groups at all visits
Measured: 7 days +/- 1 day
Difference in NEI Score between the groups at all visits
Difference in NEI Score between the groups at all visits
Measured: 7 days +/- 1 day
Subjective complaints using OSDI score
Subjective complaints in the 3 groups using OSDI score
Measured: 7 days +/- 1 day
Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups
Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups
Measured: 7 days +/- 1 day
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
Measured: 7 days +/- 1 day
Subjective complaints using VAS
Subjective complaints in the 3 groups using VAS
Measured: 7 days +/- 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start14 Apr 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, PrimUnivPrDr, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064189
- Sponsor's protocol ID
- Lacrimera Staining
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT05064189
- Acronym / sponsor ID
- Lacrimera Staining
- Conditions
- Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –15 patients will be included in group 1 (no additional treatment) |
| Group 2 | Experimental | Device: Lacrimera15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre) |
| Group 3 | Experimental | Device: Lacrimera15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacrimeraA 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. | Device | Group 2, Group 3 |
Primary outcome
Difference in National Eye Institute Grading Scale (NEI Score)
Time frame: Day 0
Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery
7 secondary outcomes
Difference in NEI Score between all visits post-operatively in the different groups
Time frame: 7 days +/- 1 day
Difference in break-up time and non-invasive break-up time between the groups at all visits
Time frame: 7 days +/- 1 day
Difference in NEI Score between the groups at all visits
Time frame: 7 days +/- 1 day
Subjective complaints using OSDI score
Time frame: 7 days +/- 1 day
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
Difference in number of MMP-9 positive eyes
Time frame: 7 days +/- 1 day
Subjective complaints using VAS
Time frame: 7 days +/- 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, PrimUnivPrDr principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacrimera in people with Eye Diseases, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in National Eye Institute Grading Scale (NEI Score) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.