An interventional study of Carmellose eye drops in Dry Eye, Dry Eye Disease and Kerato Conjunctivitis Sicca, 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
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.
Tear Film \& Ocular Surface Society Dry Eye Workshop (TFOS DEWS) II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology (to the extent that this can be determined), as well as disease severity.
First-line for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants.
Carboxymethyl cellulose (CMC) is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface.
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 "Ocular drops based upon carmellose" 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 "Ocular drops based upon carmellose" according 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 (V0), one of the "Ocular drops based upon carmellose" products can be dispensed to the enrolled subject, depending on Investigator clinical evaluation and decision.
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 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) and their eye-surgery history (if applicable).
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →C.O.C. Farmaceutici S.r.l. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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: Carmellose eye drops
Ocular drops based upon carmellose
Change in Schirmer Test I: to evaluate the lubricant and protecting performance of the "Ocular drops based upon carmellose" used as Intended in subjects with mild or severe dry eye syndrome, through the Schirmer I test
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "Ocular drops based upon carmellose" used as Intended 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 eye-discomfort relieving performance of the "Ocular drops based upon carmellose", through OSDI
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
To evaluate the safety and tolerability of the "Ocular drops based upon carmellose", 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: Very satisfied High score means better outcome.
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)
Ran from Mar 2022 to primary completion in Jul 2022, 4 months.
Of 113 industry-sponsored interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 4 months is below that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
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.