Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Eyestil SYNFO

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03001
    • Oftalvist
  • Córdoba, Spain, 14012
    • Hospital Arruzafa
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Zaragoza, Spain, 50004
    • Hospital Nuestra Señora de Gracia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects with signs and symptoms of ocular discomfort resulting from ocular dryness.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SIFI SpA
• Investigators: Study Director: Claudine Civiale, SIFI S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dry eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 053/SI SYNFO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No