Dry EyeNCT05825599
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
A study testing Hydroxypropyl methylcellulose eye drops in people with Dry Eye and Dry Eye Disease, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- What is being tested?
- Hydroxypropyl methylcellulose 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
- 6 Sep 2022to 30 Jan 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 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.
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 Ospedaliera Policlinico Mater Domini - Università Magna Grecia di Catanzaro
Catanzaro, CZ, 88100
About this study
Official title: 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.
Read more
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.
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Being tested
- Hydroxypropyl methylcellulose 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.
Hydroxypropyl methylcellulose eye dropsDevice
Hydroxypropyl methylcellulose (HPMC)-based eyedrops
| Study group | Role | What they receive |
|---|---|---|
| Eyedrops treatment arm | Experimental | Not described Receives: Device: Hydroxypropyl methylcellulose 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 "HPMC-based eyedrops" used to relieve dry eye symptoms by moisturizing and lubricating the ocular surface, through Schirmer I test
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30)
Secondary outcomes (4)
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
Measured: 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
Measured: 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)
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Measured: End of study visit (EOS/V2 = Day 30)
To evaluate the patient satisfaction of the "HPMC-based eyedrops" through a 5-points Likert Scale
Measured: End of study visit (EOS/V2 = Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start6 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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)
Sponsor and investigators
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825599
- Sponsor's protocol ID
- COC-R3-HPMC
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05825599
- Acronym / sponsor ID
- COC-R3-HPMC
- Conditions
- Dry Eye, Dry Eye Disease, 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
- 6 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 24 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.
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 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: Hydroxypropyl methylcellulose 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 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.
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 |
|---|---|---|
| Hydroxypropyl methylcellulose eye dropsHydroxypropyl methylcellulose (HPMC)-based eyedrops | Device | Eyedrops treatment arm |
Primary outcome
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)
4 secondary outcomes
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)
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)
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)
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)
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 24 Apr 2023.
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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 Hydroxypropyl methylcellulose eye drops in people with Dry Eye and Dry Eye Disease, 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 24 Apr 2023. 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 "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)). 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 24 Apr 2023.