Dry Eye DiseaseNCT06955585
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
A study testing Proluxx Artificial Tear Spray in people with Dry Eye Disease and Dry Eye, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
This clinical study involves patients with Dry Eye Disease (DED) who are visiting an ophthalmology outpatient clinic. Eligible participants must have an Ocular Surface Disease Index (OSDI) score ≥14 and <50, and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test <10 mm/5 min… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Dry Eye, Dry Eye, Evaporative
- What is being tested?
- Proluxx Artificial Tear Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 25 Apr 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular Surface Disease Index (OSDI) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test (≤10 mm/5 min), or positive corneal staining based on the Oxford grading scheme. In addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy
Who cannot join
- use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This clinical study involves patients with Dry Eye Disease (DED) who are visiting an ophthalmology outpatient clinic. Eligible participants must have an Ocular Surface Disease Index (OSDI) score ≥14 and <50, and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test <10 mm/5 min, or positive corneal staining based on the Oxford grading scale. At baseline, tear film thickness will be measured using Pentacam imaging. Participants will then receive Proluxx eye spray, applied four times daily for 28 days. After this treatment period, a follow-up examination with all baseline assessments will be repeated.
Read the detailed description
This clinical trial aims to evaluate the effects of Proluxx artificial tear spray in patients diagnosed with Dry Eye Disease (DED). Participants are recruited from an ophthalmology outpatient clinic and must have had symptoms of DED for at least 3 months. Inclusion criteria include an Ocular Surface Disease Index (OSDI) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test (≤10 mm/5 min), or positive corneal staining based on the Oxford grading scheme. In addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy.
Exclusion criteria include the use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months.
The goal of the study is to classify patients based on DED subtype: hyposecretory, evaporative, or mixed. The study will analyze clinical parameters at baseline, including OSDI score, TBUT, Schirmer test, Oxford staining, CPTFT (central precorneal tear film thickness) measured by Pentacam, BCVA (best corrected visual acuity), intraocular pressure (IOP), and risk factors. Participants will use Proluxx artificial tear spray four times daily for 28 days. After the treatment period, all baseline assessments will be repeated.
The study will compare clinical findings from Day 0 and Day 28 to assess changes in ocular surface health and tear film quality following therapy.
- Conditions
- Dry Eye Disease, Dry Eye, Dry Eye, Evaporative
- Being tested
- Proluxx Artificial Tear Spray
- Keywords
- dry eye, artificial tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proluxx Artificial Tear SprayDevice
Also called Proluxx Duo sprej za oko
Topical artificial tear spray applied to closed eyelids four times daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Proluxx Treatment Group | Experimental | Group that will use topical artificial tear spray applied to closed eyelids four times daily for 28 days. Receives: Device: Proluxx Artificial Tear Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Precorneal Tear Film Thickness (CPTFT)
Change in central precorneal tear film thickness measured using Pentacam imaging between baseline and after 28 days of treatment with Proluxx artificial tear spray.
Measured: Baseline (Day 0) and Day 28
Change in Ocular Surface Disease Index (OSDI) Score
Change in OSDI questionnaire score to evaluate improvement in symptoms of dry eye disease after 28 days of therapy.
Measured: Baseline and Day 28
Secondary outcomes (2)
Change in Tear Break-Up Time (TBUT)
Measurement of tear film stability by TBUT test, comparing values at baseline and after 28 days of treatment.
Measured: Baseline and Day 28
Change in Corneal Staining Grade (Oxford Scale)
Assessment of ocular surface damage using Oxford grading of corneal staining at baseline and after treatment.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start25 Apr 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danijel Mikulic, University Hospital Sestre Milosrdnice
- Investigators
- Ivanka Petric Vicković, Prof,MD,PHD, Study director, Eye Department of UHC Sestre milosrdnice Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955585
- Sponsor's protocol ID
- DED-2025
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT06955585
- Acronym / sponsor ID
- DED-2025
- Conditions
- Dry Eye Disease, Dry Eye, Dry Eye, Evaporative
- Keywords
- dry eye, artificial tears
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 May 2025 (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.
This clinical study involves patients with Dry Eye Disease (DED) who are visiting an ophthalmology outpatient clinic. Eligible participants must have an Ocular Surface Disease Index (OSDI) score ≥14 and <50, and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test <10 mm/5 min, or positive corneal staining based on the Oxford grading scale. At baseline, tear film thickness will be measured using Pentacam imaging. Participants will then receive Proluxx eye spray, applied four times daily for 28 days. After this treatment period, a follow-up examination with all baseline assessments will be repeated.
Detailed description
This clinical trial aims to evaluate the effects of Proluxx artificial tear spray in patients diagnosed with Dry Eye Disease (DED). Participants are recruited from an ophthalmology outpatient clinic and must have had symptoms of DED for at least 3 months. Inclusion criteria include an Ocular Surface Disease Index (OSDI) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test (≤10 mm/5 min), or positive corneal staining based on the Oxford grading scheme. In addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy.
Exclusion criteria include the use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months.
The goal of the study is to classify patients based on DED subtype: hyposecretory, evaporative, or mixed. The study will analyze clinical parameters at baseline, including OSDI score, TBUT, Schirmer test, Oxford staining, CPTFT (central precorneal tear film thickness) measured by Pentacam, BCVA (best corrected visual acuity), intraocular pressure (IOP), and risk factors. Participants will use Proluxx artificial tear spray four times daily for 28 days. After the treatment period, all baseline assessments will be repeated.
The study will compare clinical findings from Day 0 and Day 28 to assess changes in ocular surface health and tear film quality following therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proluxx Treatment Group | Experimental | Device: Proluxx Artificial Tear SprayGroup that will use topical artificial tear spray applied to closed eyelids four times daily for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular Surface Disease Index (OSDI) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (TBUT) <7 seconds, Schirmer I test (≤10 mm/5 min), or positive corneal staining based on the Oxford grading scheme. In addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy
Key exclusion criteria (1 listed)
- use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months
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 |
|---|---|---|
| Proluxx Artificial Tear SprayAlso: Proluxx Duo sprej za okoTopical artificial tear spray applied to closed eyelids four times daily for 28 days. | Device | Proluxx Treatment Group |
Primary outcome
Change in Central Precorneal Tear Film Thickness (CPTFT)
Time frame: Baseline (Day 0) and Day 28
Change in central precorneal tear film thickness measured using Pentacam imaging between baseline and after 28 days of treatment with Proluxx artificial tear spray.
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: Baseline and Day 28
Change in OSDI questionnaire score to evaluate improvement in symptoms of dry eye disease after 28 days of therapy.
2 secondary outcomes
Change in Tear Break-Up Time (TBUT)
Time frame: Baseline and Day 28
Change in Corneal Staining Grade (Oxford Scale)
Time frame: Baseline and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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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.
Ivanka Petric Vicković, Prof,MD,PHD study director
Eye Department of UHC Sestre milosrdnice Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proluxx Artificial Tear Spray in people with Dry Eye Disease and Dry Eye, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danijel Mikulić, MD (00385989956997, danijel.mikulic@kbcsm.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central Precorneal Tear Film Thickness (CPTFT) (time frame: Baseline (Day 0) and Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.