A Phase 3 interventional study of Vizol S DIGI EYE eye drops and 0,9% saline solution, eye drops in Dry Eye Disease (DED), sponsored by Jadran Galenski laboratorij d.d.. Completed at 3 sites in Serbia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Jadran Galenski laboratorij d.d. · Phase 3, Interventional, and Supportive care
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 86 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Jadran Galenski laboratorij d.d. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
1 drop 4 times a day
Also known as: Test, (T)
1 drop 4 times a day
Also known as: Control, (C)
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.
Time frame: baseline and week 2 follow up
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
Time frame: 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)
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
Time frame: 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)
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.
Time frame: 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)
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 = (\[sum of scores for all questions answered\*100\]/\[total number of questions answered\*4\]).
Time frame: 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)
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.
Time frame: baseline, week 2 follow-up and week 4 follow-up
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.
Time frame: baseline and 0, 4 and 8±1 hour after 1st application
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.
Time frame: baseline and 0, 4 and 8±1 hour after 1st application
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.
Time frame: 0, 0.25 and 1 hour after 1st application
The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period
The patients will be asked to report any Pre-Treatment Sign and symptom/Adverse Events (PTSS/AEs) spontaneously.
Time frame: baseline, week 2 follow-up and week 4 follow-up
Best-corrected visual acuity (BCVA)
Best corrected visual acuity (BCVA) will be assessed at each visit. BCVA assessment will be at 4 meters using an ETDRS chart (The Early Treatment Diabetic Retinopathy Study Group). Results will be calculated as logMAR scores. The logMAR scale (logarithm of the Minimum Angle of Resolution) ranges approximately from -0.3 to 1.0, where lower scores indicate better visual acuity and higher scores indicate worse visual acuity.
Time frame: baseline, week 2 follow-up and week 4 follow-up
Frequency of ocular signs
Ocular signs will be assessed by slit-lamp examination at all study visits. The following signs will be assessed: • active inflammation or significant structural change or discharge (eyelids and conjunctiva); • active inflammation or active structural change, including focal scarring and fine deposition (cornea); • active inflammation (iris and anterior chamber); • level of lens opacity, pseudophakia, or aphakia (lens, with an emphasis on the visual axis)
Time frame: baseline, week 2 follow-up and week 4 follow-up
Change in tolerability assessment score (TAS) on Visit 1 (day 1)
Tolerability Assessment Score will be assessed on Day 1 following instillation. The symptoms (burning sensation, stinging sensation, blur, and foreign body sensation) will be evaluated using a a 10-point Likert scale, where 0 indicates no symptom and 10 indicates the most severe symptom. Tolerability Assessment Score will be listed and evaluated descriptively (number of patients (N), arithmetic mean, standard deviation (SD), median, minimum, and maximum). Results for 0-5 and 6-10 scores will be summarized using counts and percentages.
Time frame: Day 1
Plan to share: No — Individual Participant Data (IPD) are available to the Health Authorities upon request
Ran from Mar 2024 to primary completion in Aug 2024, 5 months.
Of 81 industry-sponsored phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 5 months is below that.
Counting every sponsor, half of 96 studies reached it within 10 months; a quarter within 7 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Jadran Galenski laboratorij d.d.