An interventional study of Eye drops for itchy and water eyes in Allergic Conjunctivitis, Dry Eye and Dry Eye Disease, sponsored by C.O.C. Farmaceutici S.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by C.O.C. Farmaceutici S.r.l. · Not applicable, Interventional, and Treatment
Allergic conjunctivitis (or ocular allergy) and dry eye disease (DED) are two major ocular surface disorders affecting millions of people. A typical clinical symptom of allergic conjunctivitis is itching which is also observed in subjects suffering from DED. Common symptoms of DED also include a foreign body sensation, dryness, irritation, burning sensation and visual disturbance. Patients with allergic conjunctivitis or moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.
Gel-based artificial tear supplements may offer longer retention times and act as a supplement to the mucin layer. Carbomer (also known as Carbopol polymers) is awater-soluble polymeric resin that exhibit excellent viscoelastic and mucoadhesive properties when compared with other polymers. Carbomer is used in liquid or semisolid pharmaceutical, cosmetics, and ophthalmic formulations as rheology modifiers. Aqueous carbomer gels have been used for the treatment of dry eye and allergic conjunctivitis as they provide prolonged ocular residence time of conventional ophthalmic solutions. Furthermore, carbomer has shown compatibility with many active ingredients, good thermal stability, excellent organoleptic characteristics, and good patient acceptance.
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 "Optrex Double Action soothing and lubricating drops" for itchy and watery eyes.
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 the use of "Optrex Double Action soothing and lubricating drops" 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, "Optrex Double Action soothing and lubricating drops" will be prescribed 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.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →C.O.C. Farmaceutici S.r.l. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Eye drops for itchy and water eyes
Ocular drops for itchy and watery eyes
Change in Schirmer I test: to evaluate the performance of "Optrex Double Action soothing and lubricating drops" as soothing and lubricating eye drops for itchy and watery eyes, through the Schirmer I 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 "Optrex Double Action soothing and lubricating drops" used to provide relief from eye discomfort associated with itchy and watery eyes, through OSDI
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
To evaluate the safety and tolerability of "Optrex Double Action soothing and lubricating drops" 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.
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
Rensis Likert 5 points patient satisfaction scale Minimum value: Very dissatisfied Maximum value: Vert satisfied Higher scores mean a better outcome
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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C.O.C. Farmaceutici S.r.l.