Dry EyePhase 4TANAMINCT07809022
Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery
A Phase 4 study testing LACRIFILL® Canalicular Gel administration in people with Dry Eye and Dry Eye Disease (DED), run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 99 years
- Conditions the study is for
- Dry Eye, Dry Eye Disease (DED), Dry Eye Sensation After Cataract Surgery
- What is being tested?
- LACRIFILL® Canalicular Gel administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Phase 4
- 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 45 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated bilateral cataract surgery for age-related cataract within the last 2-7 days
- Implantation of the same type of lens in both eyes (diopters may differ).
- Age 45-99 years
- Willingness to complete the study
- Signed informed consent form
Who cannot join
- Bilateral cataract due to a different cause
- Retinal findings affecting quality of life or visual acuity in any eye
- History of uncontrolled glaucoma in any eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
- Active or suspected ocular or periocular infection in the study eye.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, State of Vienna, 1090
Gregor S. Reiter, MD, PhD, BA, MSc, +43 1 40400 73419, gregor.reiter@meduniwien.ac.at
Johannes Schrittwieser, MD, +43 1 40400 73557, johannes.schrittwieser@meduniwien.ac.at
About this study
Official title: Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery in a Prospective Randomized Controlled Inter-eye Study
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.
- Being tested
- LACRIFILL® Canalicular Gel administration, Sham lacrimal canalicular procedure
- Keywords
- dry eye disease, hyaluronic acid, lacrimal plug
- 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.
LACRIFILL® Canalicular Gel administrationDevice
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.
Sham lacrimal canalicular procedureProcedure or surgery
Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.
| Study group | Role | What they receive |
|---|---|---|
| LACRIFILL® Canalicular Gel Lacrimal Occlusion | Experimental | 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. Receives: Device: LACRIFILL® Canalicular Gel administration |
| Lacrimal Irrigation | Sham comparator | 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. Receives: Procedure: Sham lacrimal canalicular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 month; 3 months
Number of applied artifical tear drops
Self-reported number of average applications of artificial tear drops per eye per day.
Measured: 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.
Measured: 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
Measured: 1 month; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, contralateral-eye controlled study. Within each participant, one eye is randomly assigned to temporary lacrimal occlusion with LACRIFILL® Canalicular Gel and the fellow eye to a sham lacrimal irrigation procedure. Each participant therefore receives both interventions, with treatment allocation randomized at the eye level.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Reiter, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809022
- Sponsor's protocol ID
- 1058/2026
- Acronym
- TANAMI
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery in a Prospective Randomized Controlled Inter-eye Study
- ClinicalTrials.gov ID
- NCT07809022
- Acronym / sponsor ID
- TANAMI / 1058/2026
- Keywords
- dry eye disease, hyaluronic acid, lacrimal plug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, contralateral-eye controlled study. Within each participant, one eye is randomly assigned to temporary lacrimal occlusion with LACRIFILL® Canalicular Gel and the fellow eye to a sham lacrimal irrigation procedure. Each participant therefore receives both interventions, with treatment allocation randomized at the eye level.
| Arm | Type | Receives |
|---|---|---|
| LACRIFILL® Canalicular Gel Lacrimal Occlusion | Experimental | Device: LACRIFILL® Canalicular Gel administrationWithin 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. |
| Lacrimal Irrigation | Sham comparator | Procedure: Sham lacrimal canalicular procedureThe 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. |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Uncomplicated bilateral cataract surgery for age-related cataract within the last 2-7 days
- Implantation of the same type of lens in both eyes (diopters may differ).
- Age 45-99 years
- Willingness to complete the study
- Signed informed consent form
Key exclusion criteria (5 listed)
- Bilateral cataract due to a different cause
- Retinal findings affecting quality of life or visual acuity in any eye
- History of uncontrolled glaucoma in any eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
- Active or suspected ocular or periocular infection in the study eye.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye.
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 |
|---|---|---|
| LACRIFILL® Canalicular Gel administrationLACRIFILL® 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. | Device | LACRIFILL® Canalicular Gel Lacrimal Occlusion |
| Sham lacrimal canalicular procedureLacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion. | Procedure or surgery | Lacrimal Irrigation |
Primary outcome
Inter-eye difference in Schirmer Test 1 at month 1
Time frame: 1 months
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.
9 secondary outcomes
Inter-eye difference in Schirmers Test 1 at month 3
Time frame: 3 Months
Inter-eye difference in Oxford grading at month 1 and months 3
Time frame: 1 month, 3 months
Inter-eye difference in tear break up time (TBUT) at month 1 and 3
Time frame: 1 month; 3 months
Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3
Time frame: 1 month; 3 months
Halo/glare size measured with the Real Artificial Lens Vision (RALV) system
Time frame: 1 month and 3 months
Outcomes of questionnaires
Time frame: 1 month; 3 months
Number of applied artifical tear drops
Time frame: 3 months
Incidence of adverse events and device- or procedure-related adverse events
Time frame: 3 months
Inter-eye difference in visual quality assessment
Time frame: 1 month; 3 months
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 9 Sep 2026.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LACRIFILL® Canalicular Gel administration in people with Dry Eye and Dry Eye Disease (DED), run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 5 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 9 Sep 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-eye difference in Schirmer Test 1 at month 1 (time frame: 1 months). 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 9 Sep 2026.