Clinical trial NCT05778942: Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects with signs and symptoms of ocular discomfort resulting from ocular dryness.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Keratitis lesions
timeFrame: 1 month
Secondary outcomes:
measure: Keratitis Lesions
timeFrame: Day 14 and at 3 months
measure: Conjuctival Hyperemia
timeFrame: Day 14, 1 month and 3 months
measure: Best Corrected Visual Acuity
timeFrame: Day 14, 1 month and 3 months
measure: Tear Film Stability Break-Up time
timeFrame: Day 14, 1 month and 3 months
measure: SANDE Questionnaire
timeFrame: 1 and 3 months
measure: DEQS Questionnaire
timeFrame: 1 and 3 months
measure: Number of Adverse Events
timeFrame: From date of randomization up to 3 months
measure: Investigator Global Assessment Score
timeFrame: From date of randomization up to 3 months
measure: Intra Ocular Pressure
timeFrame: From date of randomization up to 3 months
measure: Number and status (empty/unused) of returned devices
timeFrame: Day 14, 1 month and 3 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Oftalvist
city: Córdoba
country: Spain
facility: Hospital Arruzafa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Zaragoza
country: Spain
facility: Hospital Nuestra Señora de Gracia
Study officials:
affiliation: SIFI S.p.A.
name: Claudine Civiale
role: STUDY_DIRECTOR
References: