Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness

NCT05778942 | Completed

• 1 other identifier: 053/SI SYNFO
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 4

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

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Keratitis Lesions

  Day 14 and at 3 months

• Conjuctival Hyperemia

  Day 14, 1 month and 3 months

• Best Corrected Visual Acuity

  Day 14, 1 month and 3 months

• Tear Film Stability Break-Up time

  Day 14, 1 month and 3 months

• SANDE Questionnaire

  1 and 3 months

Study Arms (1)

Single Arm

Single arm with commercial study drug: Eyestil SYNFO

Device: Eyestil SYNFO

Interventions

Eyestil SYNFO DEVICE

Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (4)

Oftalvist

Alicante, 03001, Spain

Location

Hospital Arruzafa

Córdoba, 14012, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Nuestra Señora de Gracia

Zaragoza, 50004, Spain

Location

Related Publications (1)

• Molero Senosiain M, Burgos-Blasco B, Perez-Garcia P, Sanchez-Ventosa A, Villalba-Gonzalez M, Lopez Perez MD, Diaz JC, Diaz-Mesa V, Villarrubia Cuadrado A, Artiaga Elordi E, Larrosa Poves JM, Blasco A, Mateo A, Civiale C, Bonino L, Cano-Ortiz A. Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation. Ophthalmol Ther. 2025 Apr;14(4):675-692. doi: 10.1007/s40123-025-01099-x. Epub 2025 Feb 21.

  PMID: 39984804 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Claudine Civiale

  SIFI S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 22, 2023
• Study Start: February 23, 2023
• Primary Completion: November 6, 2023
• Study Completion: December 19, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)