Vizol S DIGI EYE Efficacy and Safety Study in Patients With Dry Eye

NCT07050446 | Completed Phase 3

• 1 other identifier: JGL02-Vizol S_DIGI EYE 23
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S DIGI EYE, a new eye drops, solution developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 28 days.

Conditions

Dry Eye Disease (DED)

Keywords

KCS; DED; dry eye syndrome; moderate dry eye disease; severe dry eye disease; evaporative DED; menthol; digital device; digital screen; eye strain; fatigue; keratoconjunctivitis sicca (KCS)

Outcome Measures

Primary Outcomes (1)

• Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 14)

  Tear film break-up time (TBUT) will be assessed 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. Two measurements per eye will be performed and the mean value documented and used for evaluation.

  baseline and week 2 follow up

Secondary Outcomes (8)

• Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 28)

  baseline and week 4 follow up

• percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 14) and from Visit 1 (baseline) to Visit 3 (day 28)

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

• change in the tear film break-up time (TFBUT) on Visit 1 (day 1)

  baseline and 4 hour after 1st application

• Mean change in ocular surface disease index (OSDI) score from Visit 1 (baseline) to Visit 2 (day 14) and Visit 3 (day 28)

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

• Mean changes in ocular surface staining score (OSS) (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 2 (day 14) and Visit 1 to Visit 3 (day 28)

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

Other Outcomes (4)

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

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

• Best-corrected visual acuity (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 DIGI EYE

EXPERIMENTAL

topical administration of 1 drop of Vizol S DIGI EYE in each eye 4 times a day for 28 days

Drug: Vizol S DIGI EYE eye drops

0,9% saline solution, eyedrops

PLACEBO COMPARATOR

topical administration of 1 drop of 0,9% saline solution, eyedrops matching Vizol S DIGI EYE in each eye 4 times a day for 28 days

Drug: 0,9% saline solution, eye drops

Interventions

Vizol S DIGI EYE eye drops DRUG

1 drop 4 times a day

Also known as: Test, (T)

Vizol S DIGI EYE

0,9% saline solution, eye drops DRUG

1 drop 4 times a day

Also known as: Control, (C)

0,9% saline solution, eyedrops

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age;
• Diagnosis of moderate to severe dry eye disease (DED) with a baseline
• Ocular Surface Disease Index (OSDI) score ≥23 (approximately 15% of the population should wear contact lenses);
• Tear Film Break-Up Time (TBUT) \<10 s in one or both eyes at baseline;
• National Eye Institute (NEI) score for corneal fluorescein surface staining \>5/15 and for conjunctival fluorescein surface staining \>6/18 at baseline;
• Best corrected visual acuity (BCVA) of ≥20/80 (or ≥55 letters score or ≥0.6 Early Treatment Diabetic Retinopathy Study log of the minimum angle of resolution value) in both eyes at screening;
• Use of electronic devices (e.g., computers, laptops, smart phones, tablets, televisions (TVs), electronic book readers) with digital screens for more than 6 hours daily;
• Use of eyelid hygiene for at least 14 days prior to screening;
• 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:

• History of hypersensitivity or intolerance to any component of investigational product (IP);
• History of hypersensitivity to fluorescein;
• Any active ocular disease or any anterior ocular surface findings (diseases and irregularities) other than dry eye disease;
• Ocular or refractive surgery (e.g., LASIK, photorefractive keratectomy (PRK) etc.) within the last 12 months from screening;
• Current punctual occlusion of any type;
• History of ocular trauma;
• History of herpes simplex or herpes zoster keratitis;
• History of any type of corneal ulcers;
• Any other acute or chronic disease which may interfere with the aims of the clinical trial or other relevant ocular pathology judged by the investigator that preclude safe administration of the IPs;
• Systemic diseases that alter the ocular surface;
• History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator;
• History of malignancy (other than localized basal cell carcinoma of the skin or in situ cervical cancer);
• Use any topical ophthalmic medication within the last 30 days (except for artificial tears or lubricants; patients will be required to discontinue any other artificial tear or lubricants within the last 14 days and during the trial);
• Use of systemic medications that may contribute to dry eye (unless on a stable regimen for ≥30 days before screening and throughout the study);
• History of or current drug or alcohol dependence;

Sponsors & Collaborators

• Jadran Galenski laboratorij d.d.: lead
• Poseidon Clinical Research Balkans LLC: collaborator

Study Sites (3)

Special eye hospital - Beogradski oftalmološki centar

Belgrade, Belgrade, 11000, Serbia

Location

Laser Centre Vid

Kragujevac, Kragujevac, 34000, Serbia

Location

Specialized clinic for eye disease - klinika Veselinović

Niš, Niš, 18000, Serbia

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia; Fatigue; Keratoconjunctivitis Sicca

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• D. Veselinović, Prof. dr

  Specialized clinic for eye disease - 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: Multicentre, randomized, controlled, double-blind, parallel design clinical study

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 3, 2025
• Study Start: March 20, 2024
• Primary Completion: August 23, 2024
• Study Completion: November 2, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)