Dry EyeNCT05825586
PMCF Study to Evaluate Performance and Safety of "Distilled Waters-based Eyedrops" Used to Relieve Dry Eye Symptoms
A study testing Distilled waters based 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. The typical symptoms of DED include irritation, discomfort, blurred or fluctuating vision. 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?
- Distilled waters based eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2022to 27 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 ICF;
- Patients with ophthalmic discomfort due to atmospheric agents and/or environmental factors, contact lenses wearing or 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 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 "Distilled Waters-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. The typical symptoms of DED include irritation, discomfort, blurred or fluctuating vision.
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
Distilled waters of natural herbs such as Green Tea, Calendula, Chamomile, Hamamelis and Euphrasia are known for their soothing and refreshing properties. Thanks to the combined action of these natural elements, distilled waters-based eyedrops are particularly indicated to relieve eye dryness, irritation and redness of the eyes' mucosa caused by atmospheric agents, environmental factors, and/or use of contact lenses.
"Distilled waters-based eyedrops" medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action.
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 "Distilled waters-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 "Distilled waters-based eyedrops" according to the 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 "Distilled waters-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.
The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to 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).
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Being tested
- Distilled waters based 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.
Distilled waters based eye dropsDevice
Distilled Waters (DW)-based eyedrops
| Study group | Role | What they receive |
|---|---|---|
| Eyedrops treatment arm | Experimental | Not described Receives: Device: Distilled waters based 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 "DW-based eyedrops" used as intended to relieve eye mucosa' irritation and redness due to atmospheric agents, environmental factors, and/or use of contact lenses, through Schirmer I test
Measured: From baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
Secondary outcomes (3)
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "DW-based eyedrops" used as intended to ensure relief from eye discomfort sensation (e.g. eye strain, dryness, itching, and burning), through OSDI
Measured: From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
To evaluate the safety and tolerability of the "Distilled waters-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 "DW-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 start2 Aug 2022
- Primary completion27 Jan 2023
- Study completion27 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
- 60 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
- NCT05825586
- Sponsor's protocol ID
- COC-R2-DW
- 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 "Distilled Waters-based Eyedrops" Used to Relieve Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT05825586
- Acronym / sponsor ID
- COC-R2-DW
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 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. The typical symptoms of DED include irritation, discomfort, blurred or fluctuating vision.
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.
Distilled waters of natural herbs such as Green Tea, Calendula, Chamomile, Hamamelis and Euphrasia are known for their soothing and refreshing properties. Thanks to the combined action of these natural elements, distilled waters-based eyedrops are particularly indicated to relieve eye dryness, irritation and redness of the eyes' mucosa caused by atmospheric agents, environmental factors, and/or use of contact lenses.
"Distilled waters-based eyedrops" medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action.
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 "Distilled waters-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 "Distilled waters-based eyedrops" according to the 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 "Distilled waters-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.
The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to 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).
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: Distilled waters based 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 ICF;
- Patients with ophthalmic discomfort due to atmospheric agents and/or environmental factors, contact lenses wearing or 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 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 |
|---|---|---|
| Distilled waters based eye dropsDistilled Waters (DW)-based eyedrops | Device | Eyedrops treatment arm |
Primary outcome
Change in Schirmer Test I: to evaluate the performance of "DW-based eyedrops" used as intended to relieve eye mucosa' irritation and redness due to atmospheric agents, environmental factors, and/or use of contact lenses, through Schirmer I test
Time frame: From baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
3 secondary outcomes
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "DW-based eyedrops" used as intended to ensure relief from eye discomfort sensation (e.g. eye strain, dryness, itching, and burning), through OSDI
Time frame: From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
To evaluate the safety and tolerability of the "Distilled waters-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 "DW-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 Distilled waters based 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 "DW-based eyedrops" used as intended to relieve eye mucosa' irritation and redness due to atmospheric agents, environmental factors, and/or use of contact lenses, through Schirmer I test (time frame: From baseline (V0 = Day 0) at 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.