Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness

Study Overview
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Brief Summary
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This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness

Detailed Description
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Primary objective ▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline. Secondary objectives To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline. To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline. To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. To compare patients reported outcomes with baseline, using specifically: the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment; the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment. To evaluate the safety and compliance of the medical device throughout the entire study period.

Official Title
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Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Eyestil SYNFO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18 years or older Subject able to provide Informed Consent, in compliance with 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 eye dryness in one or both eyes as determined by: Scoring of ocular surface staining with fluorescein using the NEI scale (summing the score of cornea and conjunctiva, the total score per single eye range should be at least ≥6 on the 0-33 NEI scale) TFBUT with fluorescein ≤10 seconds. The TFBUT value will be recorded as the average of 3 measurements SANDE questionnaire ≥35 Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator Exclusion Criteria: Corneal injuries or abrasions of traumatic origin 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 Concomitant treatment with drugs that may interfere with tear gland secretion Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) 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 Pathologies associated with corneal thinning

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Single arm with commercial study drug: Eyestil SYNFO | Device: Eyestil SYNFO<br>* Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratitis lesions | To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratitis Lesions | To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the National Eye Institute scale compared to baseline. | Day 14 and at 3 months | 
| Conjuctival Hyperemia | To evaluate conjunctival hyperemia index by OCULUS keratograph | Day 14, 1 month and 3 months | 
| Best Corrected Visual Acuity | To evaluate changes in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. | Day 14, 1 month and 3 months | 
| Tear Film Stability Break-Up time | The conjunctival tear film stability break-up time (TFBUT) will be evaluated after the instillation of 5 µl of a 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac- of each eye. The TFBUT value will be the average of 3 measurements. | Day 14, 1 month and 3 months | 
| SANDE Questionnaire | To compare patients reported outcomes with baseline, using the Symptom Assessment questionnaire iN Dry Eye (SANDE) questionnaire | 1 and 3 months | 
| DEQS Questionnaire | To compare patients reported outcomes with baseline, using the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire | 1 and 3 months | 
| Number of Adverse Events | To evaluate the safety through general assessment of adverse events | From date of randomization up to 3 months | 
| Investigator Global Assessment Score | To evaluate the safety using the Investigator Global Assessment Score | From date of randomization up to 3 months | 
| Intra Ocular Pressure | To evaluate the safety using the measurement of the intraocular pressure | From date of randomization up to 3 months | 
| Number and status (empty/unused) of returned devices | To evaluate compliance based on treatment administration and returned medical devices | Day 14, 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye