Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery

NCT07809022 | Not Yet Recruiting Phase 4

• 1 other identifier: 1058/2026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye; Dry Eye Disease (DED); Dry Eye Sensation After Cataract Surgery

Keywords

dry eye disease; hyaluronic acid; lacrimal plug

Outcome Measures

Primary Outcomes (1)

• 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.

  1 months

Secondary Outcomes (9)

• Inter-eye difference in Schirmers Test 1 at month 3

  3 Months

• Inter-eye difference in Oxford grading at month 1 and months 3

  1 month, 3 months

• Inter-eye difference in tear break up time (TBUT) at month 1 and 3

  1 month; 3 months

• Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3

  1 month; 3 months

• Halo/glare size measured with the Real Artificial Lens Vision (RALV) system

  1 month and 3 months

Study Arms (2)

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.

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.

Procedure: Sham lacrimal canalicular procedure

Interventions

LACRIFILL® Canalicular Gel administration DEVICE

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.

LACRIFILL® Canalicular Gel Lacrimal Occlusion

Sham lacrimal canalicular procedure PROCEDURE

Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.

Lacrimal Irrigation

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology and Optometry

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ap.Prof. PD. DDr. BA, MSc,

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 9, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

AU (1)