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T-PRED

Phase 3

Cataract | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Oct 20, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment236

FDA Designations

No designations recorded

Clinical trial landscape

T-PRED · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00854061Study of T-PRED(TM) Compared to Pred Forte(R) IICataract
COMPLETED172 Analytics
PHASE3COMPLETED
Study of T-PRED(TM) Compared to Pred Forte(R) II
CataractUnlock trial analytics

Study Endpoints

Primary Endpoints

Means Aqueous Humor Prednisolone Acetate Concentration
35 days
Mean Aqueous Humor Prednisolone Acetate Concentration
4 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
T-PredEXPERIMENTALTobramycin prednisolone acetate combination
Pred ForteACTIVE_COMPARATORPrednisolone acetate

Interventions

NameTypeDescription
T-PredDRUGsterile ophthalmic solution
Pred ForteDRUGsterile ophthalmic solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years of age or older Exclusion Criteria: * No active or adverse disease

Countries:United States
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Frequently asked questions about T-PRED

What is T-PRED used for?

T-PRED is an investigational small molecule being developed for use in cataract surgery. It is a corticosteroid designed to manage inflammation following cataract procedures. The drug is currently in clinical development and has not been approved by the FDA.

Who makes T-PRED?

T-PRED is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients undergoing cataract surgery.

What phase is T-PRED in?

T-PRED is in Phase 3 clinical development. It has completed two trials, including a Phase 2 study and a Phase 3 study, both of which were conducted in the United States. The drug remains investigational and is not yet approved.

What clinical trials is T-PRED in?

T-PRED has completed two clinical trials. The first, NCT00699803, was a Phase 2 study comparing T-PRED to Pred Forte in 64 cataract patients. The second, NCT00854061, was a Phase 3 study comparing T-PRED to Pred Forte in 172 cataract patients. Both trials were randomized, double-blind, and active-controlled.

Is T-PRED the same as Pred Forte?

No, T-PRED is not the same as Pred Forte. T-PRED is an investigational drug being developed by Bausch + Lomb, while Pred Forte is a commercially available corticosteroid used as an active comparator in clinical trials. The trials directly compared the two treatments for cataract-related inflammation.