Dry Eye DiseaseNCT07793344
Four-Week Ocular-Surface Evaluation of an Experimental Ophthalmic Liposomal Nanocarrier in Dry Eye Disease
A study testing Experimental ophthalmic liposomal nanocarrier in people with Dry Eye Disease, run by Regional Specialist Hospital in Wroclaw at 1 site in Poland.
Trial summary
This prospective, single-group research medical experiment evaluated the ocular-surface response to repeated bilateral use of an experimental ophthalmic liposomal nanocarrier in adults with dry eye disease. Participants used one drop in each eye three times daily (morning, midday, and evening) for four weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Experimental ophthalmic liposomal nanocarrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePoland
- Study dates
- 17 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with dry eye disease diagnosed by an ophthalmologist.
- Written informed consent.
- Ability to attend baseline and follow-up assessments and use the study formulation for approximately four weeks.
Who cannot join
- Pregnancy
- Breastfeeding
- Ocular diseases or conditions considered by the examining ophthalmologist likely to interfere with study assessments or confound the study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-Group Research Medical Experiment Evaluating Four-Week Ocular-Surface and Tear-Film Response to an Experimental Ophthalmic Liposomal Nanocarrier in Adults With Dry Eye Disease
This prospective, single-group research medical experiment evaluated the ocular-surface response to repeated bilateral use of an experimental ophthalmic liposomal nanocarrier in adults with dry eye disease. Participants used one drop in each eye three times daily (morning, midday, and evening) for four weeks. Clinical assessments were performed at baseline and follow-up and included ocular-surface staining, tear-film stability, tear-volume measures, symptoms, and contextual ophthalmic measures. A nested optical assessment evaluated tear-film surface regularity and non-invasive tear-film parameters.
Read the detailed description
The study was conducted at the Regional Specialist Hospital in Wroclaw within project POIR.04.01.01-00-0016/19 as a research medical experiment under Polish law and was not classified as a medicinal-product clinical trial under the applicable national regulatory framework. The Bioethics Committee at the Regional Specialist Hospital in Wroclaw approved the research programme (KB/02/2021; 31 March 2021), and participants provided written informed consent.
Twenty-six participants were recruited. Twenty-one completed the approximately four-week clinical follow-up. One clinical completer was excluded from the nested optical analysis because excessive ocular movement prevented reliable interferometric signal acquisition, leaving 20 participants in the optical substudy.
The original exploratory research programme did not designate a single confirmatory efficacy endpoint. The protocol-defined assessment framework was multidomain and included visual acuity, slit-lamp examination, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT tear-meniscus assessment, LIPCOF assessment, corneal fluorescein staining, conjunctival lissamine-green staining, central corneal thickness, intraocular pressure, posterior-segment assessment, Ocular Surface Disease Index, and optical tear-film measurements.
This ClinicalTrials.gov record was created retrospectively in 2026 to improve transparency and support scientific publication. Retrospective registration does not imply prospective registration and does not alter the original legal classification of the study in Poland.
- Conditions
- Dry Eye Disease
- Being tested
- Experimental ophthalmic liposomal nanocarrier
- Keywords
- Ocular Surface, Tear Film, Liposomal Nanocarrier, Ophthalmic Formulation
- 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.
Experimental ophthalmic liposomal nanocarrierOther
One drop was instilled into each eye three times daily (morning, midday, and evening) for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental liposomal nanocarrier | Experimental | Participants instilled the experimental ophthalmic liposomal nanocarrier bilaterally for four weeks. Receives: Other: Experimental ophthalmic liposomal nanocarrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protocol-defined multidomain ocular-surface clinical assessment profile
The exploratory protocol assessed ocular-surface and tear-film response using a predefined examination panel rather than a single confirmatory efficacy endpoint. The panel included corneal fluorescein staining, conjunctival lissamine-green staining, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT-derived tear-meniscus height, Ocular Surface Disease Index, intraocular pressure, central corneal thickness, LIPCOF, visual acuity, slit-lamp examination, and posterior-segment assessment. The record intentionally does not retrospectively designate one of these measures as the sole primary efficacy endpoint.
Measured: Baseline to end of the approximately 4-week use period
Secondary outcomes (1)
Change in optical tear-film parameters in the nested optical substudy
The nested optical substudy assessed tear-film surface regularity using lateral shearing interferometry (M2_LSI and interblink slope a_LSI) and non-invasive tear-film parameters using an Ocular Surface Analyser, including tear-meniscus height, non-invasive break-up time, and lipid-layer thickness.
Measured: Baseline to approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start17 Mar 2022
- Primary completion31 May 2022
- Study completion30 Jun 2022
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group prospective before-and-after evaluation with baseline and approximately four-week follow-up assessments.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Specialist Hospital in Wroclaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793344
- Sponsor's protocol ID
- WSS-KB02-2021-LIPONANO
- Other IDs
- POIR.04.01.01-00-0016/19-00
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing because the dataset contains clinical data from human participants and is subject to ethical approval, participant-consent, data-protection, and project-related restrictions. Requests for access to de-identified data may be considered on a case-by-case basis, subject to applicable ethical, legal, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Group Research Medical Experiment Evaluating Four-Week Ocular-Surface and Tear-Film Response to an Experimental Ophthalmic Liposomal Nanocarrier in Adults With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07793344
- Acronym / sponsor ID
- WSS-KB02-2021-LIPONANO
- Conditions
- Dry Eye Disease
- Keywords
- Ocular Surface, Tear Film, Liposomal Nanocarrier, Ophthalmic Formulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Regional Specialist Hospital in WroclawUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Aug 2026 (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 prospective, single-group research medical experiment evaluated the ocular-surface response to repeated bilateral use of an experimental ophthalmic liposomal nanocarrier in adults with dry eye disease. Participants used one drop in each eye three times daily (morning, midday, and evening) for four weeks. Clinical assessments were performed at baseline and follow-up and included ocular-surface staining, tear-film stability, tear-volume measures, symptoms, and contextual ophthalmic measures. A nested optical assessment evaluated tear-film surface regularity and non-invasive tear-film parameters.
Detailed description
The study was conducted at the Regional Specialist Hospital in Wroclaw within project POIR.04.01.01-00-0016/19 as a research medical experiment under Polish law and was not classified as a medicinal-product clinical trial under the applicable national regulatory framework. The Bioethics Committee at the Regional Specialist Hospital in Wroclaw approved the research programme (KB/02/2021; 31 March 2021), and participants provided written informed consent.
Twenty-six participants were recruited. Twenty-one completed the approximately four-week clinical follow-up. One clinical completer was excluded from the nested optical analysis because excessive ocular movement prevented reliable interferometric signal acquisition, leaving 20 participants in the optical substudy.
The original exploratory research programme did not designate a single confirmatory efficacy endpoint. The protocol-defined assessment framework was multidomain and included visual acuity, slit-lamp examination, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT tear-meniscus assessment, LIPCOF assessment, corneal fluorescein staining, conjunctival lissamine-green staining, central corneal thickness, intraocular pressure, posterior-segment assessment, Ocular Surface Disease Index, and optical tear-film measurements.
This ClinicalTrials.gov record was created retrospectively in 2026 to improve transparency and support scientific publication. Retrospective registration does not imply prospective registration and does not alter the original legal classification of the study in Poland.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group prospective before-and-after evaluation with baseline and approximately four-week follow-up assessments.
| Arm | Type | Receives |
|---|---|---|
| Experimental liposomal nanocarrier | Experimental | Other: Experimental ophthalmic liposomal nanocarrierParticipants instilled the experimental ophthalmic liposomal nanocarrier bilaterally for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older with dry eye disease diagnosed by an ophthalmologist.
- Written informed consent.
- Ability to attend baseline and follow-up assessments and use the study formulation for approximately four weeks.
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding
- Ocular diseases or conditions considered by the examining ophthalmologist likely to interfere with study assessments or confound the study outcomes.
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 |
|---|---|---|
| Experimental ophthalmic liposomal nanocarrierOne drop was instilled into each eye three times daily (morning, midday, and evening) for four weeks. | Other | Experimental liposomal nanocarrier |
Primary outcome
Change in protocol-defined multidomain ocular-surface clinical assessment profile
Time frame: Baseline to end of the approximately 4-week use period
The exploratory protocol assessed ocular-surface and tear-film response using a predefined examination panel rather than a single confirmatory efficacy endpoint. The panel included corneal fluorescein staining, conjunctival lissamine-green staining, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT-derived tear-meniscus height, Ocular Surface Disease Index, intraocular pressure, central corneal thickness, LIPCOF, visual acuity, slit-lamp examination, and posterior-segment assessment. The record intentionally does not retrospectively designate one of these measures as the sole primary efficacy endpoint.
1 secondary outcome
Change in optical tear-film parameters in the nested optical substudy
Time frame: Baseline to approximately 4 weeks
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 28 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing because the dataset contains clinical data from human participants and is subject to ethical approval, participant-consent, data-protection, and project-related restrictions. Requests for access to de-identified data may be considered on a case-by-case basis, subject to applicable ethical, legal, and institutional requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental ophthalmic liposomal nanocarrier in people with Dry Eye Disease, run by Regional Specialist Hospital in Wroclaw at 1 site in Poland.
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 3 inclusion and 3 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 28 Aug 2026. 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 Poland. 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?
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?
Change in protocol-defined multidomain ocular-surface clinical assessment profile (time frame: Baseline to end of the approximately 4-week use period). 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 28 Aug 2026.