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

Multicentric Clinical Investigation on the Use of Single-dose Ophthalmic Solution Based on Hyaluronate Sodium Phosphate in the Treatment of Eye Discomfort in Particular in Case of Ocular Dryness

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.

Study Overview

• Status: Completed
• Conditions: Ocular Dryness
• Intervention / Treatment: Device: Hyalistil Bio PF

Detailed Description

Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90142
    • U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone"
  • CT
    • Catania, CT, Italy, 951251
      • P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica,

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

1. Subjects (male or female) must be ≥ 18 years of age;
2. 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);

3. 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.
4. Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator;
5. Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication;
6. Subject who in physician's opinion will benefit from this treatment.

Exclusion Criteria:

1. Corneal injuries or abrasions of traumatic origin in the eye of study;
2. 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);
3. Sjögren's syndrome;
4. Stevens-Johnson syndrome;
5. Systemic lupus erythematosus;
6. Pathologies associated with corneal thinning;
7. Taking drugs that may interfere with tear gland secretion (beta -blockers);
8. 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;
9. Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study;
10. Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device.
11. Participation in another clinical trial within the previous 30 days;
12. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein Staining	The NEI/Industry Workshop scale (1995) is an ophthalmological rating scale developed by the National Eye Institute (NEI, USA) to measure the degree of corneal and conjunctival staining after instillation of fluorescein or rose bengal/lissamine green.; The cornea is divided into 5 zones: Central, Superior, Inferior, Nasal, Temporal. Each zone is assigned a score from 0 to 3: 0 = no staining; 1 = mild; 2 = moderate; 3 = severe (Lower values=better outcomes - Total maximum cornea staining = 15).; The bulbar conjunctiva is divided into 6 areas: Superior nasal, Inferior nasal, Superior temporal, Inferior temporal, Superior (under the upper eyelid, less frequently assessed), Inferior (above the inferior fornix). The total maximum conjunctiva staing is 18. The total staining score is given by the sum of the corneal and conjunctival staining (Lower values=better outcomes - Min=0, Max=33).	Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit)
SANDE	The SANDE questionnaire (Symptom Assessment in Dry Eye) is a very simple, validated tool to assess dry eye symptoms. It's based on two visual analog scale (VAS) questions that measure: 1) Frequency of symptoms (dry and irritated); 2) Severity of symptoms (dryness and irritation). Each question is scored by the patients on a 0-100 mm VAS line (0 = no symptoms, 100 = maximum symptoms), marking the point that they feel represents their perception of their current state. Data collected from the SANDE questionnaire were calculated by multiplying the frequency score by the severity score and obtaining the square root.	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).	To evaluate the degree of satisfaction of patients to the treatment we used the visual analogue scale (VAS) ranging from 0 to 100 mm in a horizontal line. Patients will be asked to place a vertical mark (on the horizontal line, from 0 to100 mm) to indicate the degree of satisfaction to the treatment, where: 0-10 mm=no: 1-30 mm=very mild; 31-50 mm=mild; 51-70 mm=moderate; 71-90 mm=strong; 91-100 mm=very strong. Patients were asked to rate their level of satisfaction answering each of these questions: 1) "I feel satisfied using this treatment? ''; 2) "With this treatment, I have a feeling of freshness?"; 3) "With this treatment, I have a feeling of relief?"; 4) "This treatment contributed to reduce my pain due to eye dryness?''; 5) "This treatment is comfortable? '' The response results are expressed in frequency and percentage of the total for each of the questions in the categories "very mild", "mild", "moderate", "strong" and "very strong".	Evaluated at day 35 ± 4 of treatment
Dry Eye-Related Quality of Life (DEQS Total Score)	Quality of life was assessed using the Dry Eye-Related Quality of Life Score (DEQS) questionnaire, which includes 15 items grouped into two subscales: Symptom Burden (6 items) and Impact on Daily Life (9 items). Each item is scored on a 0 to 4 scale, with higher scores indicating worse symptoms. Subscale scores range from 0 to 24 and 0 to 36, respectively. A total DEQS score was calculated by summing all item scores and converting the raw total to a 0-100 scale, where lower scores indicate better quality of life.	Baseline (Visit 1) and Study Termination Visit (Day 35 ± 4)
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 day 14 ± 2 of treatment (Visit 2) and day 35 ± 4 of treatment (Visit 3 - Study termination)
Best Corrected Visual Acuity (BCVA)	The ETDRS chart uses a standardized, logarithmic letter chart (Sloan letters, 5 per line). Results can be reported as either logMAR values or letter scores, in our study we used the "Line method" (the smallest line where at least 3 of 5 letters are correctly read), while Visual Acuity was expressed as Snellen Distance Equivalent (meters); in the Italian decimal system, 10/10 corresponds to 6/6" or 0.0 logMAR. To maintain consistency across clinics and trials, the examination conditions were standardized as follow: Test distance 4 meters, Chart uniformly illuminated (~85 cd/m² luminance), with a white, high contrast (≥ 90%) background, the Best corrected visual acuity (BCVA) was measured with trial frame lenses. The BCVA was testing monocularly, while the patient was encouraged to read as many letters as possible, even if guessing. When the patient misses a prespecified number (3 or more errors in a row), testing stops.	Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment of Safety (IGAS)	Safety was assessed using the Investigator Global Assessment of Safety (IGAS), a 4-point categorical scale where 1 = very good safety, 2 = good safety, 3 = moderate safety, and 4 = poor safety. IGAS was evaluated at the Study Termination Visit and summarized by reporting the number and percentage of participants in each category.	Study Termination Visit (Day 35 ± 4)
Change in Intraocular Pressure (IOP)	Intraocular pressure (IOP) was measured in mmHg using Goldmann applanation tonometry after topical anesthesia with unpreserved 0.4 percent oxybuprocaine hydrochloride. IOP was assessed at three pre-specified study visits: baseline (Visit 1), Visit 2 during treatment, and the Study Termination Visit. Results were summarized by visit for all participants included in the intention-to-treat population.	Baseline (Visit 1), Visit 2 (Day 14 ± 2), and Study Termination Visit (Day 35 ± 4)
Treatment Compliance Rate	Treatment compliance was assessed during the treatment period by counting returned single-dose containers and boxes at the Study Termination Visit. Compliance was calculated as the percentage of prescribed doses administered relative to planned doses for each participant. Participants were categorized into predefined compliance categories (<50%, 50-80%, >80%) for reporting purposes.	During the treatment period, assessed at Study Termination Visit (Day 35 ± 4)

Collaborators and Investigators

• Sponsor: SIFI SpA
• Investigators: Principal Investigator: Davide Scollo, M.D., U.O.S. Oculistica "San Marco" A.O.U. Policlinico "G.Rodolico-San Marco" Catania, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 052/SI Hyalistil Bio PF Mono

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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