Dry Eye DiseasePhase 3NCT06323395
Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye
A Phase 3 study testing Vizol S LIPID BALANCE eye drops and ophthalmic saline eye drops in people with Dry Eye Disease, run by Jadran Galenski laboratorij d.d. at 2 sites in Serbia.
Trial 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. 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
- What is being tested?
- Vizol S LIPID BALANCE eye drops and ophthalmic saline eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesSerbia
- Study dates
- 1 Jun 2022to 1 Dec 2022
- 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
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites
Special eye hospital - Beogradski oftalmološki centar
Belgrade, 11000
Specialized clinic for eye desease - klinika Veselinović
Niš, 18000
About this study
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
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
- Being tested
- Vizol S LIPID BALANCE eye drops, ophthalmic saline eye drops
- Keywords
- keratoconjunctivitis sicca (KCS), KCS, DED, dry eye syndrome, moderate dry eye disease, severe dry eye disease, evaporative DED
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vizol S LIPID BALANCE eye dropsDrug
Also called Test
1 drop 4 times a day
ophthalmic saline eye dropsDrug
Also called Placebo
1 drop 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: ophthalmic saline eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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 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)
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 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)
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
Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)
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
Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30)
Meibomian gland expression will be observed by slit-lamp examination. Glands will be expressed from the temporal to the nasal aspect using a cotton-tipped applicator. Five glands in each area of the lower lid (nasal, central, temporal) will be examined.
Expressed meibum (across all glands) will be classified as follows: clear, easily expressed (grade 0), cloudy, mild pressure (grade 1), cloudy, > moderate pressure (grade 2), meibum not expressed, with hard pressure (grade 3).
Measured: baseline, week 2 follow-up and week 4 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jun 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jadran Galenski laboratorij d.d.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Poseidon CRO
- Responsible party
- Sponsor
- Investigators
- D. Veselinović, prof. dr., Principal investigator, Specialized clinic for eye desease - klinika Veselinović
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323395
- Sponsor's protocol ID
- JGL-DED-VIZ-SLB 21
- Status last verified
- Dec 2023
- First submitted
- 7 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Datas (IPDs) are available to the Health Authorities on a request
Publications
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 28736342Aguilar 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 25473263Chiambaretta 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 27445067Novack 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 28736344Vukelic K, Pejakovic TI, Krivicic Hyrat B, Vukelic Obad M, Knezevic Z, Degirmenci C, Ahmadli E, Palamar Onay M, Gokce EH, Tanriverdi ST, Ozer O. Preclinical and clinical evaluation of an ocular nanoemulsion for the treatment of dry eye disease. Expert Opin Drug Deliv. 2026 Oct 6. doi: 10.1080/17425247.2026.2727111. Online ahead of print.
PubMed 42837491
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06323395
- Acronym / sponsor ID
- JGL-DED-VIZ-SLB 21
- Conditions
- Dry Eye Disease
- Keywords
- keratoconjunctivitis sicca (KCS), KCS, DED, dry eye syndrome, moderate dry eye disease, severe dry eye disease, evaporative DED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jadran Galenski laboratorij d.d.Industry (pharma, biotech, devices)
- Collaborators
- Poseidon CRO
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study
| Arm | Type | Receives |
|---|---|---|
| Vizol S LIPID BALANCE | Experimental | Drug: Vizol S LIPID BALANCE eye dropstopical administration of 1 drop of Vizol S LIPID BALANCE in each eye 4 times a day for 30 days |
| ophthalmic saline eyedrops | Placebo comparator | Drug: ophthalmic saline eye dropstopical administration of 1 drop of ophthalmic saline eye drops matching Vizol S LIPID BALANCE in each eye 4 times a day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vizol S LIPID BALANCE eye dropsAlso: Test1 drop 4 times a day | Drug | Vizol S LIPID BALANCE |
| ophthalmic saline eye dropsAlso: Placebo1 drop 4 times a day | Drug | ophthalmic saline eyedrops |
Primary outcome
Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)
Time frame: baseline, week 2 follow-up and week 4 follow-up
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.
5 secondary outcomes
Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15)
Time frame: 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)
Time frame: 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)
Time frame: baseline, week 2 follow-up and week 4 follow-up
Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)
Time frame: 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)
Time frame: baseline, week 2 follow-up and week 4 follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Results publication: PubMed 28736342Wolffsohn 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.
- Results publication: PubMed 25473263Aguilar 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.
- Results publication: PubMed 27445067Chiambaretta 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.
- Results publication: PubMed 28736344Novack 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.
- Derived from this study: PubMed 42837491Vukelic K, Pejakovic TI, Krivicic Hyrat B, Vukelic Obad M, Knezevic Z, Degirmenci C, Ahmadli E, Palamar Onay M, Gokce EH, Tanriverdi ST, Ozer O. Preclinical and clinical evaluation of an ocular nanoemulsion for the treatment of dry eye disease. Expert Opin Drug Deliv. 2026 Oct 6. doi: 10.1080/17425247.2026.2727111. Online ahead of print.
- Individual participant dataSharing planned: No. Individual Participant Datas (IPDs) are available to the Health Authorities on a request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Veselinović, prof. dr. principal investigator
Specialized clinic for eye desease - klinika Veselinović
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vizol S LIPID BALANCE eye drops and ophthalmic saline eye drops in people with Dry Eye Disease, run by Jadran Galenski laboratorij d.d. at 2 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 5 inclusion and 20 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 (day 30) (time frame: baseline, week 2 follow-up and week 4 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 NCT06323395, which also lists 5 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 21 Mar 2024.