A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease

NCT05773963 | Terminated

• 1 other identifier: M-DED-2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Opthalomology/Dry Eye

Outcome Measures

Primary Outcomes (1)

• Evaluate the performance of Investigational Products to relieve symptoms of dry eye. The performance will be evaluated by Shirmer I test at baseline (V0) and end of study visit (change will be assessed)

  To evaluate the performance of IPs to relieve symptoms of dry eye, the Shirmer I test (ST) might be completed at baseline (V0) and end of study visit (EOS/V2). The evaluation will be performed stratified by study IPs.

  Day 0 (baseline visit the IP will be dispensed) and Day 25

Secondary Outcomes (4)

• Efficacy of Investigational Products used as intended to relieve symptoms of dry eye. The Efficacy will be evaluated by Questionnaire at baseline (V0) and end of study visit (change will be assessed)

  Day 0 (baseline visit the IP will be dispensed) and Day 25

• To assess the efficacy of Investigational Products used as intended to relieve symptoms of dry eye. The efficacy will be evaluated by Tear breakup time test at baseline (V0) and end of study visit (change will be assessed)

  Day 0 (baseline visit the IP will be dispensed) and Day 25

• Evaluation of the safety and tolerability of the Investigational Products by Visual Analogue Scale at the end of study visit

  Day 25

• The patient satisfaction will be evaluated with a 5-points Likert Scale at the end of study visit

  Day 25

Study Arms (1)

At V0, as per clinical practice, only 1 of the IPs products can be assigned to the enrolled subject

OTHER

At V0, as per clinical practice, only 1 of the IPs products can be assigned to the enrolled subject

Device: Irilens; Iridina; Afomill Lubricating Eye Drops

Interventions

Irilens; Iridina; Afomill Lubricating Eye Drops DEVICE

* Irilens (with 0.4% HA as key ingredient); * Iridina (with 0.4% HA as key ingredient); * Afomill Lubricating Eye Drops (with 0.2% HA as key ingredient and distilled water of Chamomile).

At V0, as per clinical practice, only 1 of the IPs products can be assigned to the enrolled subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Informed consent form (ICF) signed;
• M \& F Aged ≥ 18 years at the time of the signature of ICF;
• Patients with ocular symptoms such as burning, itching, and foreign body sensation due to environmental factors, life habits, contact lenses wearing
• Diagnosis of mild-severe dry eye (OSDI score \>8).
• Willing not to use other eye drops during the entire treatment period.

You may not qualify if:

• Other - different - eyes clinical conditions;
• Retinal pathology;
• Other type of ophthalmic neuropathy;
• Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases);
• Known hypersensitivity or allergy to IP components;
• Eye surgery during the previous 3 months (e.g. LASIK, cataract surgery)
• Presence of any relevant severe organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant in Investigator's opinion;
• Participation in another investigational study;
• Inability to follow all study procedures, including attending all site visits, tests and examinations;
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

• Montefarmaco OTC SpA: lead

Study Sites (2)

IRCCS Istituto Auxologico Italiano

Milan, Italy

Location

Ospedale Felice Liotti Pontedera

Pisa, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 17, 2023
• Study Start: February 24, 2022
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

IT (2)