Clinical trial NCT06323395: Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye
Official title: Multi-centre, Randomised,Parallel-group, Controlled (Placebo), Double-blind Study to Evaluate the Efficacy, Ocular Tolerability and Safety of Vizol S Lipid Balance in the Adult Patient Population With Moderate to Severe Dry Eye for up to 30 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: keratoconjunctivitis sicca (KCS)
KCS
DED
dry eye syndrome
moderate dry eye disease
severe dry eye disease
evaporative DED
Lead sponsor: Jadran Galenski laboratorij d.d.
Sponsor class: INDUSTRY
Collaborators: name: Poseidon CRO
First posted: 2024-03-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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 judged by the investigator that preclude safe administration of the IPs
* use of contact lenses within 1 week before screening and throughout the study
* active ocular disease other than DED or any other acute or chronic disease which may interfere with the aims of the clinical trial
* history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
* diagnosis of Corona Virus Disease (COVID-19) within the last 14 days prior to individual enrolment of the patient
* contact to persons in international risk areas for COVID-19 as defined by the Institute of Public Health of Serbia within the last 14 days prior to individual enrolment of the patient
* known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
* history of or current drug or alcohol dependence
* participation in an investigational drug or device study ≤30 days before screening
* positive pregnancy test at screening examination
* pregnant or lactating women
* female patients who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1)
* patients suspected or known not to follow instructions
* patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15)
timeFrame: baseline and week 2 follow-up
measure: percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30)
timeFrame: baseline and week 2 follow-up; baseline and week 4 follow-up
measure: Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30)
timeFrame: baseline, week 2 follow-up and week 4 follow-up
measure: Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)
timeFrame: baseline, week 2 follow-up and week 4 follow-up
measure: Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30)
timeFrame: baseline, week 2 follow-up and week 4 follow-up
Other outcomes:
measure: The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period
timeFrame: baseline, week 2 follow-up and week 4 follow-up
measure: BCVA
timeFrame: baseline, week 2 follow-up and week 4 follow-up
measure: Frequency of ocular signs
timeFrame: baseline, week 2 follow-up and week 4 follow-up
Locations:
city: Belgrad
country: Serbia
facility: Special eye hospital - Beogradski oftalmološki centar
city: Niš
country: Serbia
facility: Specialized clinic for eye desease - klinika Veselinović
Study officials:
affiliation: Specialized clinic for eye desease - klinika Veselinović
name: D. Veselinović, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
citation: Aguilar AJ, Marquez MI, Albera PA, Tredicce JL, Berra A. Effects of Systane((R)) Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye. Clin Ophthalmol. 2014 Nov 25;8:2365-72. doi: 10.2147/OPTH.S70623. eCollection 2014.
citation: Chiambaretta F, Doan S, Labetoulle M, Rocher N, Fekih LE, Messaoud R, Khairallah M, Baudouin C; HA-trehalose Study Group. A randomized, controlled study of the efficacy and safety of a new eyedrop formulation for moderate to severe dry eye syndrome. Eur J Ophthalmol. 2017 Jan 19;27(1):1-9. doi: 10.5301/ejo.5000836. Epub 2016 Jul 20.
citation: Novack GD, Asbell P, Barabino S, Bergamini MVW, Ciolino JB, Foulks GN, Goldstein M, Lemp MA, Schrader S, Woods C, Stapleton F. TFOS DEWS II Clinical Trial Design Report. Ocul Surf. 2017 Jul;15(3):629-649. doi: 10.1016/j.jtos.2017.05.009. Epub 2017 Jul 20.