STACLEAR is The First Fillable Syringe FDA-Cleared For Intravitreal Use

Ophthalmologists
Compounding Pharmacies
Ophthalmic Drug Companies

WHY INVENT AN INTRAVITREAL SYRINGE?

Floaters In The Eye Reported

In late 2016, the American Society of Retina Specialist (ASRS) alerted its members to the risk of floaters and intraocular pressure caused by liquid silicone oil -- the lubricant in generic insulin syringes.

The Industry Responded

Insurance companies started requiring that retina specialists have their patients sign a liability waiver before the procedure in view of this new liability risk.

The FDA Takes Steps To Ensure Patient Safety

In 2018, the Food & Drug Administration (FDA) issued new, more stringent guidelines around compounding drugs for intraocular injections, adding regulatory risk.

TriboFilm Research Was Invited to Engineer a Better Syringe:

One that meets the Food & Drug Administration's strict particulate standards for intraocular medical devices.

After 3 Years of Research & Development,

We Achieved That Goal.

Why Stop at One Problem, When We Can Fix Them All?

Our team worked closely with ophthalmologists and compounding pharmacies to understand ALL their requirements:

Improve dose accuracy with a smoother plunger movement.
Make the markings large and easy-to-read.
Reduce the need for priming to remove air bubbles.
Remove dead space.
Extend the plunger cap to make it easier and safer to ship.
Comply with FDA Guidance for 503B Facilities.

StaClear is the Result of Collaborative Design Thinking and
is Currently Available in Attached Needle (SC250AN), Luer Slip (SC 250LS):

Luer slip syringe, 100X fewer particles, Optimized design, Controlled injection experience, Easy-to-read graduation marks, Ophthalmic-safe materials , Extended plunger cap

How is StaCear Superior to Generic Syringes?

100X FEWER PARTICLES THAN GENERIC SYRINGES - Coating is anchored to the walls of the syringe versus liquid silicone oil in generic syringes.
A MORE CONTROLLED INJECTION EXPERIENCE - Elastomer piston ensures sealing integrity -- a risk in silicone-free syringes.
EASY-TO-READ GRADUATION MARKS - This enables precision dosing (0.25ml syringe with 0.01ml graduations) vs. generic options.
A LOW DEAD SPACE SYRINGE DESIGN - Compare StaClear with syringes that require $10-15 of drug wastage due to dead space.
EXTENDED CAP - Protects the retracted plunger from accidental bumps during shipping.
OPHTHALMIC-SAFE MATERIALS - Meets chemical and biocompatibility standards for ophthalmic use.

Coming Soon!

StaClear 0.25 mL

LUER LOCK Syringe

Request Information

The TriboFilm Research Team is Excited to Launch StaClear.

After years of R&D and a rigorous FDA process, it is gratifying to see significant market interest for StaClear, and receive positive client feedback.

Vinay Sakhrani

VP of Technology at TriboFilm Research & Co-Inventor

photo of Director of Technology at TriboFilm and co-inventor of StaClear

We have helped many medical device & pharma companies solve difficult lubricant challenges, but the StaClear product is my absolute favorite.

Jackson Thornton

Director of Technology at TriboFilm Research & Co-Inventor, StaClear

TriboFilm strives to earn customer satisfaction by consistently supplying safe, reliable, defect-free products that meet or exceed customer and regulatory requirements. To this end, we have established and are committed to the continual improvement of our Quality Management System, which is based on the requirements of 21 CFR Part 820 and ISO 13485:2016.

Dan Jonsen

Principal Scientist & Quality System Manager

One of my mentors receives an intravitreal injection once a month for wet AMD. Bringing this syringe to market is personally important to me.

Neesha Mirchandini

Director of Communications at TriboFilm Research

This Research Was Funded by National Eye Institute.

The National Eye Institute (through its SBIR grant program) championed and funded this important research. Thanks to its support, StaClear is the only syringe designed for ophthalmologists and in full compliance with FDA Guidance for intraocular safety.