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

Study Overview
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Brief Summary
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The puropose 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.

Detailed Description
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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.

Official Title
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Multicentric Clinical Investigation on the Use of Single-dose Ophthalmic Solution Based on Hyaluronate Sodium Phosphate in the Treatment of Eye Discomfort in Particular in Case of Ocular Dryness

Conditions
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Ocular Dryness

Intervention / Treatment
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* Device: Hyalistil Bio PF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects (male or female) must be ≥ 18 years of age; 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); 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. Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator; Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication; Subject who in physician's opinion will benefit from this treatment. Exclusion Criteria: Corneal injuries or abrasions of traumatic origin in the eye of study; 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); Sjögren's syndrome; Stevens-Johnson syndrome; Systemic lupus erythematosus; Pathologies associated with corneal thinning; Taking drugs that may interfere with tear gland secretion (beta -blockers); 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; Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study; Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device. Participation in another clinical trial within the previous 30 days; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hyalistil Bio PF|Moisturizing and lubricating ophthalmic solution|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break-up time with fluorescein (TFBUT) | 30% increase of Tear film break-up time with fluorescein (TFBUT) | Evaluated at day 35 ± 4 of treatment versus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein staining | Evaluation of the change in total score resulting from the sum of the corneal staining score and conjunctival. staining score with fluorescein using the National Eye Institute Scale (NEI) | Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline | 
| SANDE | Change in intensity and frequency of dry eye symptoms assessed by completing the questionnaire SANDE. | Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline | 
| Patients satisfaction (0 to 100 mm on the VAS scale) | Evaluation of the degree of satisfaction to the treatment reported by patients through the use of the visual analogue scale (VAS) | Evaluated at day 35 ± 4 of treatment | 
| Assessment of the quality of life (QOL) | Assessment of the quality of life (QOL) by Questionnaire about Eye Symptoms and Daily Life (DEQS) at Study Termination Visit compared to Visit 1 | Evaluated at baseline and day 35 ± 4 of treatment | 
| Tear film break-up time with fluorescein (TFBUT) | Evaluation of the change in total score resulting from the sum of the corneal staining score and conjunctival. staining score with fluorescein using the National Eye Institute Scale (NEI) | Evaluated at day 14 ± 2 of treatment versus day 35 ± 4 of treatment | 
| Best Corrected Visual Acuity (BCVA) | Changes about Best Corrected Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) | Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline | 
| Investigator Global Assessment of Safety (IGAS) | Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. | Evaluated at day 35 ± 4 of treatment | 
| Assess safety | Evaluation of reported adverse effects/incidents | During the treatment period | 
| Evaluation of intraocular pressure (IOP) | Evaluation of intraocular pressure (IOP) | Evaluated at baseline, day 14± 2 and 35 ± 4 of treatment | 
| Evaluation of compliance | Evaluation of compliance through verification of correct instillation of the medical device, counting of single dose containers and boxes | Evaluated at baseline and at day 35 ± 4 of treatment |