Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye (NCT06323395) | Clinical Trial Compass
CompletedPhase 3
Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye
Serbia64 participantsStarted 2022-06-01
Plain-language summary
The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* use of eyelid hygiene for at least 14 days prior to screening
* diagnosis of moderate to severe dry eye disease (DED), with an Ocular Surface Disease Index (OSDI) score ≥23
* Tear Film Break-Up Time (TFBUT) \<10 seconds in one or both eyes
* Meibomian gland expression of grade 2 or higher in both eyes
* written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
Exclusion Criteria:
* intolerance or hypersensitivity to any component of the Investigational Product (IPs)
* ocular or intraocular surgery or serious ocular trauma ≤6 months before enrolment
* current punctal occlusion of any type
* use of concomitant topical ocular medications within 24 hours prior to first intended administration of the IPs (except for artificial tears or lubricants; previously used artificial tears or lubricants must be suspended for the duration of the study)
* use of systemic medications that may contribute to dry eye (unless on a stable regimen for ≥30 days before screening and throughout the study)
* current or previous topical treatment of the eye with antibiotics, steroids or cyclosporin A within the last four weeks
* ocular or systemic infections or conditions (e.g., epithelial herpes simplex keratitis, vaccinia, varicella, or mycobacterial infection, fungal disease, iritis) or other relevant ocular pathology judg…
What they're measuring
1
Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)
Timeframe: baseline, week 2 follow-up and week 4 follow-up