An interventional study of Experimental ophthalmic liposomal nanocarrier in Dry Eye Disease, sponsored by Regional Specialist Hospital in Wroclaw. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Regional Specialist Hospital in Wroclaw · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Participants instilled the experimental ophthalmic liposomal nanocarrier bilaterally for four weeks.
Other: Experimental ophthalmic liposomal nanocarrier
One drop was instilled into each eye three times daily (morning, midday, and evening) for four weeks.
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.
Time frame: Baseline to end of the approximately 4-week use period
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.
Time frame: Baseline to approximately 4 weeks
Diary-documented administration of the study formulation
Participants recorded morning, midday, and evening administration separately for the right and left eye in a study diary. The protocol template therefore contained 84 scheduled bilateral administration events per participant over 28 days.
Time frame: Throughout the 28-day study-use period
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Regional Specialist Hospital in Wroclaw