Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Managem… (NCT06190028) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Management of Patients With Glaucomar or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy
Stopped: The investigation was prematurely interrupted with 65 patients enrolled due to difficulties in recruiting patients. However the results observed in the interim analysis demonstrate the performance of the investigational device.
Italy65 participantsStarted 2023-06-14
Plain-language summary
The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. The underlying assumption is that ophthalmic solutions as adjuvants for the management of IOP- or glaucoma-associated dry eye may induce a protection of the eye surface with consequent improvement of the symptoms and of the overall quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have an age ≥ 18 years,;
. Have undergone the informed consent process and have signed an approved consent form;
. Are able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgement;
. Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucoma will be based on: optic disc assessment, measurement of the retinal nerve fiber layer and neuroretinal rim with optical coherence tomography (OCT); characteristic repeatable visual field defects defined as a pattern standard deviation (PSD) with P \< 0.05, and/or glaucoma hemifield test (GHT) results outside normal limits. Diagnosis of OHT will be based on history of IOP (intraocular pressure) \> 21 mmHg in at least two occasions and normal optic disc and Humphrey visual field test;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy Assessment of dry eye symptoms from baseline
Timeframe: Day 30
2
Efficacy Assessment of vision-related function from baseline
. Are receiving an ongoing topical therapy with two or more preserved ocular hypotensive agents (e.g. beta-blockers, alpha-agonists, carbonic anydhrase inhibitors, prostaglandins) for at least 6 months and are willing to continue these treatments at unchanged dose for the entire investigation duration;
. Have a diagnosis of moderate to severe DES performed through the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test, Tear Film Break-Up Time (TFBUT), fluorescein staining of the cornea and conjunctiva (Oxford Staining Scheme). Please note that a diagnosis of DES may be performed at entry in the investigation;
. Have a Tear Film Break-Up Time (TFBUT) value \< 7 sec;
. Have performed a Humphrey Visual Field Test in the last 4 months, if not available the test will be performed during the screening visit;
Exclusion criteria
. Best corrected visual acuity score \< 20/40;
. Ischemic oculopathy;
. Contraindications to use of topical solution components used in this investigation or known allergy/hypersensitivity to any of the IRIDIUM®A gel ingredients;
. Current use/use in the past 15 days of any ocular medications other than hypotensive eye drops;
. Systemic treatments known to affect tear secretion;
. Treatment with any other therapy that, according to Investigator's judgment, could interfere with the assessment of the efficacy or incidence of adverse events;
. Any history or slit lamp evidence of eye surface diseases different from DES;
. History of ocular trauma or surgery in the past 12 months;