PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms

April 11, 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 "Hydroxypropyl Methylcellulose (HPMC)-Based Eyedrops" Used to Relieve Dry Eye Symptoms

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface.

Over the counter (OTC) artificial tears are typically the first line of dry eye treatment; they are meant to supplement the tears that cover the eye's surface. OTC products mimic the different layers of the tear film in order to maintain ocular hydration.

Hydroxypropyl methylcellulose (HPMC or hypromellose) is a synthetic modification of the natural polymer, cellulose. It has been widely used in in ophthalmologic formulations such as eye drops and gels due to its solubility in water, biocompatibility, transparency and rheological properties. Eye drops containing HPMC are conventionally used to treat tear film disturbances including dry eye symptoms.

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 "Hydroxypropyl methylcellulose (HPMC)-based eyedrops" 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 "HPMC-based eyedrops" according to the Instructions for Use (IFU).

"HPMC-based eyedrops" medical devices are ophthalmic solutions containing hydroxypropyl methylcellulose (HPMC) as key ingredient, a polymer able to relief eye discomfort thanks to its moisturizing, lubricating and muco-mimetic properties. HPMC can stabilize the tear film on the ocular surface by creating a protective, transparent and viscoelastic shield.

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), only one of the below reported "HPMC-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 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.
80

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 moderate-severe dry eye symptoms;
  • Willing not to use other eye drops during the entire treatment period.

Exclusion Criteria:

  • 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.

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: Hydroxypropyl methylcellulose eye drops
Hydroxypropyl methylcellulose (HPMC)-based eyedrops

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 performance of the "HPMC-based eyedrops" used to relieve dry eye symptoms by moisturizing and lubricating the ocular surface, through Schirmer I test
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)

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 Ocular Surface Disease Index (OSDI): to evaluate the performance of the "HPMC-based eyedrops" used to provide soothing and refreshing relief in subjects with eye discomfort sensation, through OSDI
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
Change in Tear Break-up Time (TBUT): to evaluate the protecting eye-surface performance of the "HPMC-based eyedrops" by stabilizing the tear film in subjects with moderate dry eye or severe dry eye, through the TBUT test
Time Frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
To evaluate the safety and tolerability of the "HPMC-based eyedrops" 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)

Visual Analogue Scale:

Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
End of study visit (EOS/V2 = Day 30)
To evaluate the patient satisfaction of the "HPMC-based eyedrops" through a 5-points Likert Scale
Time Frame: End of study visit (EOS/V2 = Day 30)
End of study visit (EOS/V2 = Day 30)

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.
September 6, 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.
January 30, 2023

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.
January 30, 2023

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 (Actual)

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.
April 24, 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.
April 11, 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.
April 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-R3-HPMC

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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