Dry Eye DiseaseNCT05823961

PMCF Study to Evaluate Performance and Safety of "CLHA-based Eyedrops" Used to Improve Lacrimal Abnormalities

A study testing Cross-linked hyaluronic acid eye drops in people with Dry Eye Disease and Dry Eye, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Tear dysfunction, also known as Dry Eye Disease (DED) is frequently encountered in the clinical practice. It is a multifactorial disease of the ocular surface characterized by insufficient tear production, loss of homeostasis of the tear film, increased osmotic stress of the ocular surface, ocular discomfort and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease, Dry Eye, Kerato Conjunctivitis Sicca
What is being tested?: Cross-linked hyaluronic acid eye drops
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteItaly
Study dates: 10 Jun 2022to 28 Jul 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient Informed consent form (ICF) signed;
Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
Patients with dry eye symptoms and/or redness, fatigue, discomfort of the eye or the ocular mucosa due to intrinsic or extrinsic factors such as atmospheric agents, environmental factors, inflammation, blepharitis, eye surgery, and/or use of contact lenses;
Willing not to use other eye drops during the entire treatment period.

Who cannot join

Other - different - eyes clinical conditions (e.g. glaucoma);
Suspected alcohol or drug abuse;
Known hypersensitivity or allergy to Investigational Product (IP) components;
Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, diabetes);
Participation in another investigational study;
Inability to follow all study procedures, including attending all site visits, tests and examinations;
Mental incapacity that precludes adequate understanding or cooperation.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliero-Universitaria Policlinico "G.Rodolico - San Marco"
Catania, CT, 95123

Other trials in Italy

About this study

Official title: Interventional, Non-comparative, Single-center PMCF Study to Evaluate Performance and Safety of "Cross-Linked Hyaluronic Acid (CLHA)-Based Eyedrops" Used to Improve Lacrimal Abnormalities, Even When Associated With Dry Eye Symptoms

Hyaluronic acid (HA) is a linear heteropolysaccharide (glycosaminoglycan) with unique hygroscopic, rheological, and lubricating properties. HA is naturally found at the human ocular surface where it contributes to the ocular hydration and lubrication thanks to its capability to bind water molecules.Sodium hyaluronate (SH), the salt form of HA, is widely used in artificial tears to counteract dry eye symptoms by facilitating eyelid sliding and reducing its friction on the corneal-conjunctival surface.

Conventional HA-based eye drops contain linear HA. However, artificially cross-linked HA (CLHA) has several advantages over linear HA in alleviating dry eye symptoms. The increased viscoelasticity of CLHA results in a greater stability and a better resistance to the enzymatic degradation by hyaluronidase, while preserving all the properties of linear HA. Furthermore, chemical cross-linking of HA extends its permanence on the ocular surface, thus reducing the number of instillations and increasing patients' compliance.

For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" used as intended to improve lacrimal abnormalities, even when associated with dry eye symptoms.

The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" according to the Instructions for Use (IFU).

Each subject, after signing the Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.

At baseline visit (V0), one of the "CLHA-based eyedrops" products will be administered to the enrolled subject.

The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

Conditions: Dry Eye Disease, Dry Eye, Kerato Conjunctivitis Sicca
Being tested: Cross-linked hyaluronic acid eye drops
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cross-linked hyaluronic acid eye dropsDevice
Cross-linked hyaluronic acid (CLHA)-based eyedrops

Study groups in NCT05823961
Study group	Role	What they receive
Eyedrops treatment arm	Experimental	Not described Receives: Device: Cross-linked hyaluronic acid eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Schirmer Test I: to evaluate the performance of the "CLHA-based eyedrops" used to improve lacrimal abnormalities, even when associated with dry eye symptoms due to intrinsic or extrinsic factors, through the Schirmer I test
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)

Secondary outcomes (4)

Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "CLHA-based eyedrops" used to relieve discomfort to the eyes or ocular mucosa, and eye fatigue caused by intrinsic or extrinsic factors, through OSDI
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "CLHA-based eyedrops" used to improve tear film stability in subjects with dry eye symptoms and/or after eye surgery, through the TBUT test
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
The global patient treatment tolerance to the "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" as assessed by the Visual Analogue Scale (VAS) as a difference between baseline and Day 30.
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Measured: End of study visit (EOS/V2 = Day 30 ± 2)
To evaluate the patient satisfaction through a Rensis Likert 5 points patient satisfaction scale
Rensis Likert 5 points patient satisfaction scale Minimum value: Very dissatisfied Maximum value: Very satisfied Higher scores mean a better outcome
Measured: End of study visit (EOS/V2 = Day 30 ± 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202228 Jul 2023

First posted21 Apr 2023
Study start10 Jun 2022
Primary completion28 Jun 2023
Study completion28 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dry Eye DiseaseStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05823961
Sponsor's protocol ID: COC-R5-CLHA
Status last verified: May 2023
First submitted: 11 Apr 2023
Last updated: 27 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional, Non-comparative, Single-center PMCF Study to Evaluate Performance and Safety of "Cross-Linked Hyaluronic Acid (CLHA)-Based Eyedrops" Used to Improve Lacrimal Abnormalities, Even When Associated With Dry Eye Symptoms
ClinicalTrials.gov ID: NCT05823961
Acronym / sponsor ID: COC-R5-CLHA
Conditions: Dry Eye Disease, Dry Eye, Kerato Conjunctivitis Sicca
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: C.O.C. Farmaceutici S.r.l.Industry (pharma, biotech, devices)
Study start: 10 Jun 2022 (actual)
Primary completion: 28 Jun 2023 (actual)
Study completion: 28 Jul 2023 (actual)
First posted: 21 Apr 2023 (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.

Each subject, after signing the Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.

At baseline visit (V0), one of the "CLHA-based eyedrops" products will be administered to the enrolled subject.

The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Eyedrops treatment arm	Experimental	Device: Cross-linked hyaluronic acid eye drops

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient Informed consent form (ICF) signed;
Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
Patients with dry eye symptoms and/or redness, fatigue, discomfort of the eye or the ocular mucosa due to intrinsic or extrinsic factors such as atmospheric agents, environmental factors, inflammation, blepharitis, eye surgery, and/or use of contact lenses;
Willing not to use other eye drops during the entire treatment period.

Key exclusion criteria (7 listed)

Other - different - eyes clinical conditions (e.g. glaucoma);
Suspected alcohol or drug abuse;
Known hypersensitivity or allergy to Investigational Product (IP) components;
Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, diabetes);
Participation in another investigational study;

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
Cross-linked hyaluronic acid eye dropsCross-linked hyaluronic acid (CLHA)-based eyedrops	Device	Eyedrops treatment arm

Primary outcome

Change in Schirmer Test I: to evaluate the performance of the "CLHA-based eyedrops" used to improve lacrimal abnormalities, even when associated with dry eye symptoms due to intrinsic or extrinsic factors, through the Schirmer I test
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)

4 secondary outcomes

Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "CLHA-based eyedrops" used to relieve discomfort to the eyes or ocular mucosa, and eye fatigue caused by intrinsic or extrinsic factors, through OSDI
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "CLHA-based eyedrops" used to improve tear film stability in subjects with dry eye symptoms and/or after eye surgery, through the TBUT test
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
The global patient treatment tolerance to the "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" as assessed by the Visual Analogue Scale (VAS) as a difference between baseline and Day 30.
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)
To evaluate the patient satisfaction through a Rensis Likert 5 points patient satisfaction scale
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)

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 27 Mar 2024.

Related trials for Dry Eye Disease

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R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cross-linked hyaluronic acid eye drops in people with Dry Eye Disease and Dry Eye, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.

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 7 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 27 Mar 2024. 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 Italy. 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?

Change in Schirmer Test I: to evaluate the performance of the "CLHA-based eyedrops" used to improve lacrimal abnormalities, even when associated with dry eye symptoms due to intrinsic or extrinsic factors, through the Schirmer I test (time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05823961.

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 27 Mar 2024.