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COMPLETED
NCT07806240
NA

Safety and Efficacy Study of RTP-008 (an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye

Sponsor: Zhejiang Raytone Bioscience Co.,Ltd

View on ClinicalTrials.gov

Summary

RTP-008, an absorbable tacrolimus lacrimal canalicular plug, targets two key pathophysiological mechanisms of dry eye: tear retention and local anti-inflammation. This clinical trial aims to evaluate the safety and efficacy of RTP-008 in adults with moderate to severe dry eye. The main questions it aims to answer are: * Is RTP-008 safe for the eyes? * How well does the plug work to improve dry eye? * Which size provides a better fit for the human lacrimal canaliculus after swelling? Participants will be divided into three groups: * Two groups will receive RTP-008 inserted into their lacrimal canaliculus (in two slightly different sizes). * One comparison group will receive an already approved dissolvable plug. All participants will use a standard lubricating eye drop four times a day in both eyes. All participants will attend follow-up visits for 24 weeks so doctors can check their eye health and any side effects.

Official title: A Clinical New Technology Study on Evaluating the Safety and Efficacy of RTP-008 ( an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye Treatment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-04-08

Completion Date

2026-02-28

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DEVICE

RTP-008

Insertion of RTP-008 into the lower punctum for temporary mechanical tear duct occlusion combined with local anti-inflammatory drug delivery in moderate to severe dry eye. The plug degrades naturally over time, providing sustained release of tacrolimus to treat dry eye.

DEVICE

Dissolvable Plug

Insertion of a Dissolvable Plug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye.

Locations (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, China