Dry Eye Disease
Conditions
Keywords
Ocular Surface, Tear Film, Liposomal Nanocarrier, Ophthalmic Formulation
Brief 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. 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.
Interventions
OTHERExperimental ophthalmic liposomal nanocarrier
One drop was instilled into each eye three times daily (morning, midday, and evening) for four weeks.
Sponsors
Regional Specialist Hospital in Wroclaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-group prospective before-and-after evaluation with baseline and approximately four-week follow-up assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnancy * Breastfeeding * Ocular diseases or conditions considered by the examining ophthalmologist likely to interfere with study assessments or confound the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in protocol-defined multidomain ocular-surface clinical assessment profile | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in optical tear-film parameters in the nested optical substudy | Baseline to approximately 4 weeks | 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. |
Countries
Poland
Outcome results
None listed