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Dry Eye Disease (DED)Phase 3NCT07050446

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

A Phase 3 study testing Vizol S DIGI EYE eye drops and 0,9% saline solution, eye drops in people with Dry Eye Disease (DED), run by Jadran Galenski laboratorij d.d. at 3 sites in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease (DED)
What is being tested?
Vizol S DIGI EYE eye drops and 0,9% saline solution, eye drops
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
3 sitesSerbia
Study dates
20 Mar 2024to 2 Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test;
  • History of Coronavirus Disease 2019 (COVID-19) within the last 30 days (to be defined in line with national requirements);
  • History of direct contact with insufficient protection to persons with COVID-19 within the last 14 days (to be defined in line with national requirements);
  • Pregnancy or breastfeeding;
  • Female patients with childbearing potential (any female after menarche unless postmenopausal for ≥12 months, or surgically sterilized) who are not willing to use a highly effective method of contraception during the study;
  • Positive pregnancy test, for female patients with childbearing potential only;
  • 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;
  • Participation in another clinical trial within 3 months before screening or over a period of 5 half-lives, or double duration of the biological effect of the investigational product received, whichever is longer.

Trial locations and contacts

3 sites in 1 country.

Serbia3 sites

  • Special eye hospital - Beogradski oftalmološki centar

    Belgrade, Belgrade, 11000

  • Laser Centre Vid

    Kragujevac, Kragujevac, 34000

  • Specialized clinic for eye disease - klinika Veselinović

    Niš, Niš, 18000

Other trials in Serbia

About this study

Official title: Multicentre, Randomized, Controlled, Double-blind, Parallel Design Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vizol S DIGI EYE in the Adult Patient Population With Moderate to Severe Dry Eye Disease for up to 28 Days

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.

Being tested
Vizol S DIGI EYE eye drops, 0,9% saline solution, eye drops
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)
Medical subject headings
Dry Eye Syndromes, Asthenopia, Fatigue, Keratoconjunctivitis Sicca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vizol S DIGI EYE eye dropsDrug

    Also called Test, (T)

    1 drop 4 times a day

  • 0,9% saline solution, eye dropsDrug

    Also called Control, (C)

    1 drop 4 times a day

Study groups in NCT07050446
Study groupRoleWhat they receive
Vizol S DIGI EYEExperimentaltopical administration of 1 drop of Vizol S DIGI EYE in each eye 4 times a day for 28 days
Receives: Drug: Vizol S DIGI EYE eye drops
0,9% saline solution, eyedropsPlacebo comparatortopical 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
Receives: Drug: 0,9% saline solution, eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and week 2 follow up

Secondary outcomes (8)

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

    Tear film break-up time (TFBUT) 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

    Measured: baseline and week 4 follow up

  2. 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)

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

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

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

    Tear film break-up time (TBUT) will be assessed following the instillation of fluorescein solution into the eye. On Day 1 TBUT will be assessed at two time points (baseline and 4 hours post-dose). 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.

    Measured: baseline and 4 hour after 1st application

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

    Symptoms of DED will be assessed using the Ocular Surface Disease Index (OSDI) questionnaire at each visit. The 12-item OSDI questionnaire scores range from 0 to 100, it contains 3 ocular symptom questions, 6 vision-related function questions, and 3 environmental trigger questions. Each question score ranges from 0 ("none of the time") to 4 ("all of the time"). The total score is calculated based on the following formula: Total score: OSDI = ([sum of scores for all questions answered*100]/[total number of questions answered*4]).

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

  5. 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)

    Ocular surface staining of five corneal regions and six conjunctival regions will be observed at each visit by slit-lamp examination after instillation of fluorescein respectively. Surface staining will be scored as 0 (normal, no staining), 1 (mild, superficial stippling or macropunctate staining), 2 (moderate, macropunctate staining with some coalescent areas), or 3 (severe, numerous coalescent macropunctate areas or patches). Scores will be summed to yield total corneal and total conjunctival staining scores for each eye.

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

  6. Change in Dry Eye Symptom Score (DESS) on Visit 1 (day 1)

    Dry Eye Symptom Score will be assessed, using a 10-point Likert scale, where 0 indicates no symptoms and 10 indicates the most severe symptoms, based on the change from baseline in dry eye symptom scores on day 1 (baseline and 0, 4, and 8±1 hours after 1st dose application). Median values will be documented and used for evaluation.

    Measured: baseline and 0, 4 and 8±1 hour after 1st application

  7. Change in Soothing Sensation Score (SSS) on Visit 1 (day 1)

    Soothing Sensation Score will be assessed, using a 10-point Likert scale, where 0 indicates no symptoms and 10 indicates the most severe symptoms, based on the change from baseline in soothing sensation scores on day 1 (baseline and 0, 4, and 8±1 hours after 1st dose application). Median values will be documented and used for evaluation.

    Measured: baseline and 0, 4 and 8±1 hour after 1st application

  8. Change in Refreshing Effect Score (RES) on Visit 1 (day 1)

    Refreshing Effect Score will be assessed, using a 10-point Likert scale on day 1 (0, 0.25 and 1 hour after 1st dose application), where 0 indicates no symptoms and 10 indicates the most severe symptoms. Median values will be documented and used for evaluation.

    Measured: 0, 0.25 and 1 hour after 1st application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start20 Mar 2024
  3. Primary completion23 Aug 2024
  4. Study completion2 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentre, randomized, controlled, double-blind, parallel design clinical study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050446
Sponsor's protocol ID
JGL02-Vizol S_DIGI EYE 23
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) are available to the Health Authorities upon request

Publications

  • 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.

    PubMed 28736344

  • 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.

    PubMed 27445067

  • 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.

    PubMed 25473263

  • 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.

    PubMed 28736342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vizol S DIGI EYE eye drops and 0,9% saline solution, eye drops in people with Dry Eye Disease (DED), run by Jadran Galenski laboratorij d.d. at 3 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 14) (time frame: baseline and week 2 follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050446, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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