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Aceclidine+tropicamide combination

Phase 2

Presbyopia | Small molecule | Ophthalmology |LENZ Therapeutics, Inc.|Last Updated: Sep 22, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

Aceclidine+tropicamide combination · 1 trial · 1 indication

Phase 2 1
NCT03201562A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate PresbyopiaPresbyopia
COMPLETED58 Analytics
PHASE2COMPLETED
A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
PresbyopiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye
1 hour post-treatment

Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Aceclidine+tropicamide combinationEXPERIMENTALAceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution)
AceclidineACTIVE_COMPARATORAceclidine single dose
VehicleSHAM_COMPARATORVehicle single dose

Interventions

NameTypeDescription
Aceclidine+tropicamide combinationDRUGOphthalmic Solution
AceclidineDRUGOphthalmic Solution
VehicleDRUGOphthalmic Solution
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Eligibility Criteria

Age Range48 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed; 2. Be able and willing to follow all instructions and attend study visits; 3. Be 48-64 years of ag...

Countries:United States
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Frequently asked questions about Aceclidine+tropicamide combination

What is Aceclidine + Brimonidine used for?

Aceclidine + Brimonidine is an investigational small molecule combination being developed by LENZ Therapeutics for the treatment of presbyopia and other eye diseases. It is administered as an ophthalmic solution. The drug is currently in clinical development and has not been approved by the FDA.

What does Aceclidine + Brimonidine target?

Aceclidine + Brimonidine combines aceclidine, a miotic agent that acts on the eye's muscarinic receptors to constrict the pupil, with brimonidine, an alpha-2 adrenergic receptor agonist. This combination is designed to improve near vision in presbyopia by creating a pinhole effect through pupil constriction.

Who makes Aceclidine + Brimonidine?

Aceclidine + Brimonidine is developed by LENZ Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LENZ. The company is focused on developing ophthalmic therapies for presbyopia and other eye conditions.

What phase is Aceclidine + Brimonidine in?

Aceclidine + Brimonidine is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 2 trial, both of which are finished. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is Aceclidine + Brimonidine in?

Aceclidine + Brimonidine has been studied in two completed clinical trials. NCT05936489 was a Phase 1 study evaluating plasma pharmacokinetics and safety in healthy adults with presbyopia. NCT03201562 was a Phase 2 trial of PRX-100, an earlier formulation, for early to moderate presbyopia.

Is Aceclidine + Brimonidine the same as LNZ101?

Aceclidine + Brimonidine is the combination of aceclidine and brimonidine, and it is also known as LNZ101. The Phase 1 trial NCT05936489 evaluated both LNZ101 and LNZ100 ophthalmic solutions in healthy subjects with presbyopia.