Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye Discomfort

SIFI SpA28 enrolled

Overview

The purpose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.

Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ocular Dryness

Interventions

Hyalistil Bio PFDEVICE

Moisturizing and lubricating ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects (male or female) must be ≥ 18 years of age; 2. Subject able to provide Informed Consent, in compliance with the good clinical practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects); 3. Subjects with ocular discomfort resulting from mild to moderate dry eye in one or both eyes determined by: * Scoring of ocular surface staining with fluorescein using the National Eye Institute (NEI) scale. Total score per single eye range 6-33 summing the score of cornea and conjunctiva. (Considering a normal score of 0-33); * Tear film break-up time with fluorescein (TFBUT) ≤ 10 seconds; The TFBUT value will be recorded as the average of 3 measurements; * Symptom Assessment in Dry Eye (SANDE) questionnaire ≥ 35. 4. Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator; 5. Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication; 6. Subject who in physician's opinion will benefit from this treatment. Exclusion Criteria: 1. Corneal injuries or abrasions of traumatic origin in the eye of study; 2. Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye); 3. Sjögren's syndrome; 4. Stevens-Johnson syndrome; 5. Systemic lupus erythematosus; 6. Pathologies associated with corneal thinning; 7. Taking drugs that may interfere with tear gland secretion (beta -blockers); 8. Patients using any topical therapies such as non-steroidal antiinflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) the eye of study; 9. Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study; 10. Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device. 11. Participation in another clinical trial within the previous 30 days; 12. Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results.

Locations (2)

P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica,

Catania, CT, Italy

U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone"

Palermo, Italy

Outcomes

Primary Outcomes

Tear Film Break-up Time With Fluorescein (TFBUT)

The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.

Time frame: Evaluated at Visit 1 (baseline) and Visit 3 (day 35 ± 4 - study termination)

Secondary Outcomes

Fluorescein Staining

The NEI/Industry Workshop scale (1995) is an ophthalmological rating scale developed by the National Eye Institute (NEI, USA) to measure the degree of corneal and conjunctival staining after instillation of fluorescein or rose bengal/lissamine green. * The cornea is divided into 5 zones: Central, Superior, Inferior, Nasal, Temporal. Each zone is assigned a score from 0 to 3: 0 = no staining; 1 = mild; 2 = moderate; 3 = severe (Lower values=better outcomes - Total maximum cornea staining = 15). * The bulbar conjunctiva is divided into 6 areas: Superior nasal, Inferior nasal, Superior temporal, Inferior temporal, Superior (under the upper eyelid, less frequently assessed), Inferior (above the inferior fornix). The total maximum conjunctiva staing is 18. The total staining score is given by the sum of the corneal and conjunctival staining (Lower values=better outcomes - Min=0, Max=33).

Time frame: Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit)

SANDE

The SANDE questionnaire (Symptom Assessment in Dry Eye) is a very simple, validated tool to assess dry eye symptoms. It's based on two visual analog scale (VAS) questions that measure: 1) Frequency of symptoms (dry and irritated); 2) Severity of symptoms (dryness and irritation). Each question is scored by the patients on a 0-100 mm VAS line (0 = no symptoms, 100 = maximum symptoms), marking the point that they feel represents their perception of their current state. Data collected from the SANDE questionnaire were calculated by multiplying the frequency score by the severity score and obtaining the square root.

Data from ClinicalTrials.gov

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