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 range18 Years
SexALL
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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;
✓. 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;
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
✓. 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;