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Triesence

Phase 2FDA approved 2007

Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Jul 10, 2018

Triesence development status

FDA approval Nov 29, 2007
Approval holderAlcon Res
ApplicationNDA022223
Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2009

Triesence target and mechanism

ModalitySmall molecule

Also known as triamcinolone acetonide injectable

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment137

FDA Designations

No designations recorded

Triesence clinical trials

Triesence · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00532415Safety and Efficacy of Vitreous Delineating Agent During VitrectomyVitrectomy
COMPLETED60 Analytics
PHASE3COMPLETED
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
VitrectomyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
Day 0

A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.

Intraocular Pressure (IOP)
1 day, 1week, 1 month, 3 month and 6 month post-op visits

Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.

Secondary Endpoints

Anterior Chamber Inflammation (Flare)
1 month, 3 month and 6 month post-op visits
Bleb Appearance
1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Patient Comfort
1 day, 1 week, 1 month, 3 month and 6 month post-op visits
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Study Design & Arms

AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TriamcinoloneEXPERIMENTALApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
Treatment 1(Triesence)EXPERIMENTALglaucoma surgery with 0.2cc Triesence adjunct.
Treatment 2 (balanced salt solution BSS)ACTIVE_COMPARATORglaucoma surgery with balanced salt solution, the standard technique.

Interventions

NameTypeDescription
Triamcinolone Acetonide Injectable SuspensionDRUGApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
TriesenceDRUGAt end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
balanced salt solution BSSDRUGAt end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patients under 18. * Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history...

Countries:United States
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Frequently asked questions about Triesence

What is Triesence used for in glaucoma?

Triesence is an investigational small molecule being studied for use in glaucoma. It is being evaluated for its ability to lower eye pressure during glaucoma surgery and improve surgical outcomes. The drug is in Phase 2 clinical development and is not yet approved for this use.

Who makes Triesence?

Triesence is being developed by Alcon Inc., a company traded under the ticker ALC. Alcon is conducting clinical research on the drug for the treatment of glaucoma.

What phase is Triesence in?

Triesence is in Phase 2 clinical development. It is an investigational drug for glaucoma and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed.

What clinical trials is Triesence in?

Triesence has been studied in a completed Phase 2 clinical trial with the identifier NCT00853905. This trial enrolled 77 participants in the United States and evaluated the drug's use during glaucoma surgery to lower eye pressure and improve surgical results.

Is Triesence the same as other glaucoma treatments?

Triesence is a distinct investigational drug being developed by Alcon Inc. for glaucoma. It is being studied as an adjunct to glaucoma surgery, with the goal of reducing eye pressure and enhancing surgical outcomes.