Clinical trial NCT05777798: Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye Discomfort
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Dryness
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: The puropose 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tear film break-up time with fluorescein (TFBUT)
timeFrame: Evaluated at day 35 ± 4 of treatment versus baseline
Secondary outcomes:
measure: Fluorescein staining
timeFrame: Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline
measure: SANDE
timeFrame: Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline
measure: Patients satisfaction (0 to 100 mm on the VAS scale)
timeFrame: Evaluated at day 35 ± 4 of treatment
measure: Assessment of the quality of life (QOL)
timeFrame: Evaluated at baseline and day 35 ± 4 of treatment
measure: Tear film break-up time with fluorescein (TFBUT)
timeFrame: Evaluated at day 14 ± 2 of treatment versus day 35 ± 4 of treatment
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline
measure: Investigator Global Assessment of Safety (IGAS)
timeFrame: Evaluated at day 35 ± 4 of treatment
measure: Assess safety
timeFrame: During the treatment period
measure: Evaluation of intraocular pressure (IOP)
timeFrame: Evaluated at baseline, day 14± 2 and 35 ± 4 of treatment
measure: Evaluation of compliance
timeFrame: Evaluated at baseline and at day 35 ± 4 of treatment
Other outcomes:
Locations:
city: Catania
country: Italy
facility: P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica,
state: CT
city: Palermo
country: Italy
facility: U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone"
Study officials:
affiliation: U.O.S. Oculistica "San Marco" A.O.U. Policlinico "G.Rodolico-San Marco" Catania, Italy
name: Davide Scollo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: