CompletedNot Applicable

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

Italy28 participantsStarted 2023-03-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Tear Film Break-up Time With Fluorescein (TFBUT)

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

Trial details

NCT IDNCT05777798

SponsorSIFI SpA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-03

Results submitted2024-08-06

View on ClinicalTrials.gov More Ocular Dryness trials