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

NCT05777798 | Completed Results

• 1 other identifier: 052/SI Hyalistil Bio PF Mono
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose 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.

Conditions

Ocular Dryness

Outcome Measures

Primary Outcomes (1)

• Tear Film Break-up Time With Fluorescein (TFBUT)

  The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.

  Evaluated at Visit 1 (baseline) and Visit 3 (day 35 ± 4 - study termination)

Secondary Outcomes (6)

• Fluorescein Staining

  Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit)

• SANDE

  Evaluated at Visit 1 (baseline), Visit2 (day 14± 2) and Visit3 (35 ± 4 - study termination)

• 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

• Dry Eye-Related Quality of Life (DEQS Total Score)

  Baseline (Visit 1) and Study Termination Visit (Day 35 ± 4)

• Tear Film Break-up Time With Fluorescein (TFBUT)

  Evaluated at day 14 ± 2 of treatment (Visit 2) and day 35 ± 4 of treatment (Visit 3 - Study termination)

Other Outcomes (3)

• Investigator Global Assessment of Safety (IGAS)

  Study Termination Visit (Day 35 ± 4)

• Change in Intraocular Pressure (IOP)

  Baseline (Visit 1), Visit 2 (Day 14 ± 2), and Study Termination Visit (Day 35 ± 4)

• Treatment Compliance Rate

  During the treatment period, assessed at Study Termination Visit (Day 35 ± 4)

Interventions

Hyalistil Bio PF DEVICE

Moisturizing and lubricating ophthalmic solution

Eligibility Criteria

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

Study Population

28 male and female subjects with signs and symptoms of ocular discomfort and ocular irritation resulting from ocular dryness who qualifies for Hyalistil Bio PF treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (2)

P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica,

Catania, CT, 951251, Italy

Location

U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone"

Palermo, 90142, Italy

Location

Results Point of Contact

• Title: Clinical Development
• Organization: SIFI SpA

giulia.faraci@sifigroup.com

00390957922111

Study Officials

• Davide Scollo, M.D.

  U.O.S. Oculistica "San Marco" A.O.U. Policlinico "G.Rodolico-San Marco" Catania, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: March 14, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Locations

IT (2)