New eye drop shows promise for dry eye sufferers
NCT ID NCT05777798
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a single-dose eye drop containing hyaluronate and sodium phosphate to relieve eye discomfort, especially dryness. Twenty-eight adults with mild to moderate dry eye participated. Researchers measured how long tears stayed on the eye and checked eye surface health. The goal was to see if the drop is safe and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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28 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Aug 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica,
Catania, CT, 951251, Italy
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U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone"
Palermo, 90142, Italy