A Phase 4 interventional study of LACRIFILL® Canalicular Gel administration and Sham lacrimal canalicular procedure in Dry Eye, Dry Eye Disease (DED) and Dry Eye Sensation After Cataract Surgery, sponsored by Medical University of Vienna. Not yet recruiting at 1 site in Austria. Open to participants aged 45 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
Among 24 studies in Dry Eye Syndromes by Medical University of Vienna — 2 open to participants now, 2 under way, none of them phase 3. Dry Eye Syndromes · Medical University of Vienna.
Among the 24 studies in Dry Eye Syndromes by Medical University of Vienna, this one is the 16th largest by planned enrollment of the 22 interventional ones that give a count, is the only one that started in 2026, is one of 9 in phase 4, and was the 24th registered.
1,367 studies on the registry are indexed under Dry Eye Syndromes; 208 are open to participants now.
Browse Dry Eye Syndromes studies →2 of the 24 studies in Dry Eye Syndromes by Medical University of Vienna are open now, in 1 country. Recruiting first, the newest first:
Medical University of Vienna · Sites in Austria
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 45 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Median enrollment 40 across the 22 interventional studies, 176 across the 2 observational. Of the 19 that completed or were terminated, 0 (0%) have results posted.
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Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
2 of the studies in Dry Eye Syndromes by Medical University of Vienna that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02585414Medical University of ViennaAssessment of TFT by OCT in Healthy Subjects and Subjects With DES | 2026-12 |
| NCT07809022Medical University of ViennaTemporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery | 2027-10-01 |
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Among the 24 studies in Dry Eye Syndromes by Medical University of Vienna, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability.
This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops.
The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within each participant, one eye will be randomly assigned to receive a single intracanalicular administration of LACRIFILL® Canalicular Gel into the lower canaliculus. The intervention is intended to provide temporary occlusion of the lacrimal drainage system and thereby reduce tear drainage and increase tear retention. The fellow eye will serve as the control eye.
Device: LACRIFILL® Canalicular Gel administration
The fellow eye of each participant will undergo lacrimal irrigation as a sham procedure. No LACRIFILL® Canalicular Gel will be administered to the control eye. The control eye will otherwise receive standard postoperative care, including artificial tear supplementation, according to standard clinical practice.
Procedure: Sham lacrimal canalicular procedure
LACRIFILL® Canalicular Gel is a crosslinked hyaluronic acid hydrogel administered intracanalicularly into the lower canaliculus. Approximately 0.2 mL is administered as a single application to the randomized treatment eye to achieve temporary occlusion of the lacrimal drainage system.
Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.
Inter-eye difference in Schirmer Test 1 at month 1
Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.
Time frame: 1 months
Inter-eye difference in Schirmers Test 1 at month 3
Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 3 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.
Time frame: 3 Months
Inter-eye difference in Oxford grading at month 1 and months 3
Difference in ocular surface staining between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery, assessed using the Oxford Scheme for Ocular Surface Staining. The Oxford score ranges from 0 to 5 for each eye, with higher scores indicating greater ocular surface staining and therefore a worse outcome. The inter-eye difference is calculated as the Oxford score in the Lacrifill-treated eye minus the score in the standard-of-care eye, resulting in a possible range of -5 to +5. Negative values indicate less ocular surface staining, and therefore a better outcome, in the Lacrifill-treated eye.
Time frame: 1 month, 3 months
Inter-eye difference in tear break up time (TBUT) at month 1 and 3
Difference in Tear Film Break-Up Time (TBUT) between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery. TBUT is measured in seconds and represents the time between a complete blink and the first appearance of a break in the tear film. Higher TBUT values indicate greater tear film stability and therefore a better outcome. The inter-eye difference is calculated as the TBUT in the Lacrifill-treated eye minus the TBUT in the standard-of-care eye; positive values indicate greater tear film stability in the Lacrifill-treated eye.
Time frame: 1 month; 3 months
Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3
Tear film stability will be assessed using the first non-invasive tear break-up time (NIBUT) measured with the MS-39 anterior segment analyzer (CSO, Florence, Italy). The integrated Placido disk-based tear film analysis detects the time from the last blink to the first detected disruption of the tear film. NIBUT is recorded in seconds. Higher values indicate greater tear film stability and therefore a better outcome. Measurements will be performed separately in the Lacrifill-treated eye and the contralateral sham-treated eye.
Time frame: 1 month; 3 months
Halo/glare size measured with the Real Artificial Lens Vision (RALV) system
Halo/glare size will be quantitatively assessed using the Real Artificial Lens Vision (RALV) halo/glare test. Participants view a central white light source while optotypes are presented at decreasing radial distances from the light source. Halo/glare size is recorded as angular extent in milliradians (mrad). Higher values indicate a larger halo/glare phenomenon and therefore greater visual disturbance. Measurements will be performed separately for the Lacrifill-treated eye and the contralateral sham-treated eye.
Time frame: 1 month and 3 months
Outcomes of questionnaires
Report of the dry eye disease questionnaires (OSDI and SPEED) and the National Eye Institute Visual function questionnaire 25 at month 1 and 3
Time frame: 1 month; 3 months
Number of applied artifical tear drops
Self-reported number of average applications of artificial tear drops per eye per day.
Time frame: 3 months
Incidence of adverse events and device- or procedure-related adverse events
Incidence, nature, severity, and relationship to the investigational device and/or procedure of adverse events, including serious adverse events and serious adverse device effects.
Time frame: 3 months
Inter-eye difference in visual quality assessment
Difference in Visual quality assessment measured by Refractive Artificial Lens Vision (RALV) at month 1 and 3
Time frame: 1 month; 3 months
Start is estimated for Sep 2026; primary completion for Oct 2027, 12 months later.
Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 12 months is close to that.
Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna →