Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness (NCT05778942) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness
Spain35 participantsStarted 2023-02-23
Plain-language summary
This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects aged 18 years or older
* Subject able to provide Informed Consent, in compliance with 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 eye dryness in one or both eyes as determined by:
* Scoring of ocular surface staining with fluorescein using the NEI scale (summing the score of cornea and conjunctiva, the total score per single eye range should be at least ≥6 on the 0-33 NEI scale)
* TFBUT with fluorescein ≤10 seconds. The TFBUT value will be recorded as the average of 3 measurements
* SANDE questionnaire ≥35
* Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator
Exclusion Criteria:
* Corneal injuries or abrasions of traumatic origin
* 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
* Concomitant treatment with drugs that may interfere with tear gland secretion
* Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product)
* Treatment with topical or sys…