PMCF Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms

May 3, 2023 updated by: C.O.C. Farmaceutici S.r.l.

An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance.

Tear Film & Ocular Surface Society Dry Eye Workshop (TFOS DEWS) II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology (to the extent that this can be determined), as well as disease severity.

First-line for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants.

Carboxymethyl cellulose (CMC) is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface.

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 "Ocular drops based upon carmellose" used as intended to relieve 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 "Ocular drops based upon carmellose" according the Instructions for Use (IFU).

Each subject, after signing the Informed Consent Form, 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 "Ocular drops based upon carmellose" products can be dispensed to the enrolled subject, depending on Investigator clinical evaluation and decision.

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.

The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according the IFU, depend on various factors regarding the physiology of the patients (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses) and their eye-surgery history (if applicable).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Azienda Ospedaliera Policlinico Mater Domini - Università Magna Grecia di Catanzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient Informed consent form (ICF) signed;
  • Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
  • Patients with ocular symptoms such as burning, itching, and foreign body sensation due to environmental factors, contact lenses wearing and/or mild-severe dry eye;
  • Willing not to use other eye drops during the entire treatment period.

Exclusion Criteria:

  • Other - different - eyes clinical conditions (e.g. glaucoma);
  • Known hypersensitivity or allergy to Investigational Product (IP) components;
  • Suspected alcohol or drug abuse;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eyedrops treatment arm
Device: Carmellose eye drops
Ocular drops based upon carmellose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Schirmer Test I: to evaluate the lubricant and protecting performance of the "Ocular drops based upon carmellose" used as Intended in subjects with mild or severe dry eye syndrome, through the Schirmer I test
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "Ocular drops based upon carmellose" used as Intended to ensure relief from ophthalmic stress, through the TBUT test
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Ocular Surface Disease Index (OSDI): to evaluate the eye-discomfort relieving performance of the "Ocular drops based upon carmellose", through OSDI
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
To evaluate the safety and tolerability of the "Ocular drops based upon carmellose", through Visual Analogue Scale (VAS) - evaluation of symptoms related to dry eye disease (burning, fatigue, discomfort, redness)
Time Frame: End of study visit (EOS/V2 = Day 30 ± 2)

Visual Analogue Scale:

Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
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)

Rensis Likert 5 points patient satisfaction scale:

Minimum value: Very dissatisfied Maximum value: Very satisfied High score means better outcome.
End of study visit (EOS/V2 = Day 30 ± 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C.O.C. Farmaceutici S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COC-R4-CMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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