Allergic ConjunctivitisNCT05829499
PMCF Study to Evaluate Performance and Safety of "Xanoftal Next"
A study testing HPMC-HA eyedrops in people with Allergic Conjunctivitis and Dry Eye, 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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis, Dry Eye, Dry Eye Disease
- What is being tested?
- HPMC-HA eyedrops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2022to 6 Feb 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
- Signed patient Informed consent form (ICF);
- Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
- Patients with ophthalmic discomfort due eye allergy or other eye discomfort caused by environmental or mechanical stress (e.g. use of computer and/or smartphone), including contact lenses wearing and blepharitis;
- Willing not to use other eye drops during the entire treatment period.
Who cannot join
- 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.
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: Interventional, Non-comparative, Single-center PMCF Study to Evaluate Performance and Safety of "Xanoftal Next" Used to Attenuate Symptoms of Seasonal Allergic Conjunctivitis, Even When Associated With Dry Eye Syndrome
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. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.
Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes).
Read more
On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups.
First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration.
For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome.
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 "Xanoftal Next" according to 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, the "Xanoftal Next" product 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
- Allergic Conjunctivitis, Dry Eye, Dry Eye Disease
- Being tested
- HPMC-HA eyedrops
- Medical subject headings
- Conjunctivitis, Allergic, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPMC-HA eyedropsDevice
Ocular drops based upon HPMC and HA
| Study group | Role | What they receive |
|---|---|---|
| Eyedrops treatment arm | Experimental | Not described Receives: Device: HPMC-HA eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Schirmer I test: to evaluate the performance of "Xanoftal Next" to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome, through the Schirmer I test
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Secondary outcomes (4)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "Xanoftal Next" to ensure relief from ophthalmic stress, through the TBUT test
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "Xanoftal Next" to reduce dry eye symptoms, mild to moderate, accompanied by itching, burning, foreign body sensation, redness due intrinsic or extrinsic causes
Ocular Surface Disease Index Minimum value: 0 - none of the time Maximum value: 4 - all of the time Higher scores mean a worse outcome
Measured: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
To evaluate the safety and tolerability of the "Xanoftal Next" 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 ± 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.
- First posted25 Apr 2023
- Study start2 Dec 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- 20 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
- NCT05829499
- Sponsor's protocol ID
- COC-R9-HPMC-HA
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 May 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 6 May 2023. 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 "Xanoftal Next" Used to Attenuate Symptoms of Seasonal Allergic Conjunctivitis, Even When Associated With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT05829499
- Acronym / sponsor ID
- COC-R9-HPMC-HA
- Conditions
- Allergic Conjunctivitis, Dry Eye, Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 25 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 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. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.
Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes).
On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups.
First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration.
For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome.
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 "Xanoftal Next" according to 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, the "Xanoftal Next" product 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: HPMC-HA eyedrops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed patient Informed consent form (ICF);
- Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
- Patients with ophthalmic discomfort due eye allergy or other eye discomfort caused by environmental or mechanical stress (e.g. use of computer and/or smartphone), including contact lenses wearing and blepharitis;
- 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);
- 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;
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 |
|---|---|---|
| HPMC-HA eyedropsOcular drops based upon HPMC and HA | Device | Eyedrops treatment arm |
Primary outcome
Change in Schirmer I test: to evaluate the performance of "Xanoftal Next" to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome, 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 Tear Break-up Time (TBUT): to evaluate the performance of the "Xanoftal Next" 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)
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "Xanoftal Next" to reduce dry eye symptoms, mild to moderate, accompanied by itching, burning, foreign body sensation, redness due intrinsic or extrinsic causes
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
To evaluate the safety and tolerability of the "Xanoftal Next" 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)
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 6 May 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 HPMC-HA eyedrops in people with Allergic Conjunctivitis 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 6 May 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 I test: to evaluate the performance of "Xanoftal Next" to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome, 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?
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 6 May 2023.