Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye

NCT06323395 | Completed Phase 3

• 1 other identifier: JGL-DED-VIZ-SLB 21
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye Disease

Keywords

keratoconjunctivitis sicca (KCS); KCS; DED; dry eye syndrome; moderate dry eye disease; severe dry eye disease; evaporative DED

Outcome Measures

Primary Outcomes (1)

• Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)

  Tear film break-up time (TFBUT) will be assessed at each visit following the instillation of fluorescein solution into the eye. Fluorescein will be instilled at the outer canthus to avoid ocular surface damage, with the excess saline on the strip shaken off, or a reduced area fluorescein strip used. Viewing will take place between 1 and 3 min after instillation. Three measurements per eye will be performed and the mean value documented and used for evaluation.

  baseline, week 2 follow-up and week 4 follow-up

Secondary Outcomes (5)

• Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15)

  baseline and week 2 follow-up

• 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)

  baseline and week 2 follow-up; baseline and week 4 follow-up

• Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30)

  baseline, week 2 follow-up and week 4 follow-up

• Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)

  baseline, week 2 follow-up and week 4 follow-up

• Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30)

  baseline, week 2 follow-up and week 4 follow-up

Other Outcomes (3)

• The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period

  baseline, week 2 follow-up and week 4 follow-up

• BCVA

  baseline, week 2 follow-up and week 4 follow-up

• Frequency of ocular signs

  baseline, week 2 follow-up and week 4 follow-up

Study Arms (2)

Vizol S LIPID BALANCE

EXPERIMENTAL

topical administration of 1 drop of Vizol S LIPID BALANCE in each eye 4 times a day for 30 days

Drug: Vizol S LIPID BALANCE eye drops

ophthalmic saline eyedrops

PLACEBO COMPARATOR

topical administration of 1 drop of ophthalmic saline eye drops matching Vizol S LIPID BALANCE in each eye 4 times a day for 30 days

Drug: ophthalmic saline eye drops

Interventions

Vizol S LIPID BALANCE eye drops DRUG

1 drop 4 times a day

Also known as: Test

Vizol S LIPID BALANCE

ophthalmic saline eye drops DRUG

1 drop 4 times a day

Also known as: Placebo

ophthalmic saline eyedrops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jadran Galenski laboratorij d.d.: lead
• Poseidon CRO: collaborator

Study Sites (2)

Special eye hospital - Beogradski oftalmološki centar

Belgrade, 11000, Serbia

Location

Specialized clinic for eye desease - klinika Veselinović

Niš, 18000, Serbia

Location

Related Publications (4)

• 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.

  PMID: 28736342 RESULT

• 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.

  PMID: 25473263 RESULT

• 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.

  PMID: 27445067 RESULT

• 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.

  PMID: 28736344 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Officials

• D. Veselinović, prof. dr.

  Specialized clinic for eye desease - klinika Veselinović

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 21, 2024
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 21, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)