Montefarmaco OTC SpA

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. The reported prevalence of DED estimates vary widely, from 5% to 33%, which may reflect both differing populations and inconsistent diagnostic criteria. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. First-line therapy for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants.
Sodium hyaluronate (commonly referred to as hyaluronic acid or HA) is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans. It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute.
As a result of its coiled structure and large hydrophilic domains, HA attracts and retains a large amount of water, and therefore possesses the ability to retard water evaporation. Following instillation, HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time.
Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes. It closely mimics the properties of a normal, healthy tear film, with a longer retention time on the corneal surface than a cellulose-based tear substitute.
HA gels have also been used successfully in ophthalmic surgery for many years. As a result of their unique physical and chemical properties, HA solutions are similar to natural tears. For that reason, they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness.
For these reasons, an interventional, confirmative, post marketing clinical follow-up (PMCF) study was planned to evaluate the performance and safety of HA-based ophthalmic solutions (i.e. Irilens; Iridina; Afomill Lubricating Eye Drops) used to relieve dry eyes symptoms.
The objectives of this 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 three investigational products (IPs) containing HA as key ingredient.
The IPs are on the market with the following brand names:
Irilens;
Iridina;
Afomill Lubricating Eye Drops.
Primary
• To evaluate the performance of IPs used as intended to relieve dry eye symptoms.
Secondary
To evaluate the efficacy of IPs used as intended to relieve symptoms of DED.
To evaluate the safety and tolerability of the IPs.
To evaluate the patient satisfaction of the IPs.

Study Rationale: The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells. These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve.
Degeneration of these nerves results in cupping, a characteristic appearance of the optic disc and visual loss. The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized. Glaucoma affects more than 70 million people worldwide with approximately 10% being bilaterally blind, making it the leading cause of irreversible blindness in the world. Glaucoma can remain asymptomatic until it is severe, resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it.
The tear film is fundamental in the maintenance of the ocular surface. Any condition that adversely affects the stability and function of the tear film such as dry eye symptom, blepharitis, and meibomian gland dysfunction, dysfunctional tear film syndrome, or toxicity of topical medications may result in onset of an ocular surface disease (OSD). The symptoms of OSD may include dryness, burning or stinging, itching, irritation, tearing, photophobia, foreign-body sensation, grittiness, redness, fatigue, fluctuating visual acuity, and blurred vision.
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age. OSD is seen in approximately 15% of the general elderly population and is reported in 48% to 59% of patients with medically treated glaucoma. One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment.
Ophthalmic solutions with soothing and refreshing proprieties, as addon treatment to glaucoma therapy, could relieve the OSD symptomatology, dry eye like, in glaucoma patients, improving their quality of life.
For these reasons, an interventional, confirmative, post marketing clinical followup (PMCF) study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients.
Study Objective: The objectives of this 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 three investigational products (IPs).
The IPs are on the market with the following brand names:
Afomill Refreshing Soothing
Afomill Anti-redness Eye Drops
Iridil

A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.