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Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

Primary Purpose

Presbyopia, Refractive Errors, Eye Diseases

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine ophthalmic solution

Vehicle proprietary ophthalmic solution

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, INSIGHT Study, INSIGHT 2

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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;
Be able and willing to follow all instructions and attend study visits;
Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
Have +1.00 to -4.00 diopter(D) of sphere (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
Have ≤ 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 1

Exclusion Criteria:

Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1

Sites / Locations

INSIGHT-2 Study Site #5
INSIGHT Study Site #3
INSIGHT Study Site #1
INSIGHT Study Site #2
INSIGHT Study Site #4

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Combination ophthalmic solution (LNZ101) dosed bilaterally

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

Vehicle Ophthalmic Solution dosed bilaterally

Arm Description

LENZ 101: Aceclidine/Brimonidine combination ophthalmic solution

LENZ 100: Aceclidine ophthalmic solution

Proprietary vehicle ophthalmic solution

Outcomes

Primary Outcome Measures

Primary Efficacy Variable

Percentage of subjects with at least a 3-line improvement in near visual acuity in the study eye.

Secondary Outcome Measures

Full Information

NCT ID

NCT05431543

First Posted

June 20, 2022

Last Updated

January 10, 2023

Sponsor

Alisyn Facemire

Collaborators

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05431543

Brief Title

Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

Official Title

A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

August 6, 2022 (Actual)

Primary Completion Date

December 14, 2022 (Actual)

Study Completion Date

January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alisyn Facemire

Collaborators

ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia, Refractive Errors, Eye Diseases, Near Vision, Miosis

Keywords

Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, INSIGHT Study, INSIGHT 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination ophthalmic solution (LNZ101) dosed bilaterally

Arm Type

Experimental

Arm Description

LENZ 101: Aceclidine/Brimonidine combination ophthalmic solution

Arm Title

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

Arm Type

Experimental

Arm Description

LENZ 100: Aceclidine ophthalmic solution

Arm Title

Vehicle Ophthalmic Solution dosed bilaterally

Arm Type

Experimental

Arm Description

Proprietary vehicle ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Aceclidine+Brimonidine combination ophthalmic solution

Other Intervention Name(s)

LNZ101, Brimonidine, Aceclidine, Vehicle

Intervention Description

LNZ101-combination ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Aceclidine ophthalmic solution

Other Intervention Name(s)

LNZ100, Aceclidine, Vehicle

Intervention Description

Aceclidine alone + vehicle

Intervention Type

Drug

Intervention Name(s)

Vehicle proprietary ophthalmic solution

Other Intervention Name(s)

vehicle

Intervention Description

Proprietary vehicle ophthalmic solution

Primary Outcome Measure Information:

Title

Primary Efficacy Variable

Description

Percentage of subjects with at least a 3-line improvement in near visual acuity in the study eye.

Time Frame

1 hour post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Be able and willing to follow all instructions and attend study visits; Be 45-75 years of age of either sex and any race or ethnicity at Visit 1; Have +1.00 to -4.00 diopter(D) of sphere (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1; Have ≤ 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1; Be presbyopic as determined at Visit 1 Exclusion Criteria: Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy; Have known contraindications or sensitivity to the use of any of the study medications(s) or their components; Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye; Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alisyn Facemire, BA

Organizational Affiliation

LENZ Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

INSIGHT-2 Study Site #5

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

INSIGHT Study Site #3

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

INSIGHT Study Site #1

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

Facility Name

INSIGHT Study Site #2

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

INSIGHT Study Site #4

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

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