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Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Primary Purpose

Presbyopia, Near Vision, Miosis

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aceclidine+Brimonidine combination ophthalmic solution
Placebo
Aceclidine Ophthalmic Solution
Sponsored by
LENZ Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotic

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 a 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 all study visits; Be 45-75 years of age of either sex and any race or ethnicity at Visit 1; Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented 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 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 in either eye; Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Sites / Locations

  • Site #326
  • Site #302
  • Site #320
  • Site #321
  • Site #328
  • Site #338
  • Site #331
  • Site #303
  • Site #313
  • Site #334
  • Site #322
  • Site #306
  • Site #337
  • Site #304
  • Site #308
  • Site #316
  • Site #319
  • Site #309
  • Site #317
  • Site #301
  • Site #307
  • Site #324
  • Site #336
  • Site #330
  • Site #335
  • Site #310
  • Site #332
  • Site #329
  • Site #323
  • Site #333
  • Site #312
  • Site #315
  • Site #311
  • Site #314
  • Site #327
  • Site #318

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Combination ophthalmic solution (LNZ101) dosed bilaterally

Placebo (Vehicle) ophthalmic solution dosed bilaterally

Aceclidine ophthalmic solution dosed bilaterally

Arm Description

LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution

Placebo: Proprietary Vehicle Ophthalmic Solution

LNZ 100: Aceclidine ophthalmic solution

Outcomes

Primary Outcome Measures

Primary Objective
Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
August 4, 2023
Sponsor
LENZ Therapeutics, Inc
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05753189
Brief Title
Phase 3 Safety Study for the Treatment of Presbyopia Subjects
Official Title
Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LENZ Therapeutics, Inc
Collaborators
ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Detailed Description
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Near Vision, Miosis, Eye Diseases
Keywords
Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination ophthalmic solution (LNZ101) dosed bilaterally
Arm Type
Experimental
Arm Description
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Arm Title
Placebo (Vehicle) ophthalmic solution dosed bilaterally
Arm Type
Placebo Comparator
Arm Description
Placebo: Proprietary Vehicle Ophthalmic Solution
Arm Title
Aceclidine ophthalmic solution dosed bilaterally
Arm Type
Experimental
Arm Description
LNZ 100: Aceclidine ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine+Brimonidine combination ophthalmic solution
Other Intervention Name(s)
LNZ101
Intervention Description
Combination ophthalmic solution of Aceclidine and Brimonidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo: Proprietary Vehicle Solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine Ophthalmic Solution
Other Intervention Name(s)
LNZ100
Intervention Description
Aceclidine
Primary Outcome Measure Information:
Title
Primary Objective
Description
Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.
Time Frame
7 visits over a total duration of approximately 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be able and willing to provide written informed consent and sign a 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 all study visits; Be 45-75 years of age of either sex and any race or ethnicity at Visit 1; Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented 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 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 in either eye; Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at 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
Site #326
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Site #302
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site #320
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Site #321
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Site #328
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Site #338
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Site #331
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Site #303
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Site #313
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Site #334
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Site #322
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Site #306
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Site #337
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Site #304
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Site #308
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Site #316
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site #319
City
Crystal River
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Site #309
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Site #317
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Site #301
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Site #307
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Site #324
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Site #336
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Site #330
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Site #335
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Site #310
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Site #332
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Site #329
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site #323
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Site #333
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site #312
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Site #315
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Site #311
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Site #314
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Site #327
City
San Antonio
State/Province
Texas
ZIP/Postal Code
33309
Country
United States
Facility Name
Site #318
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 3 Safety Study for the Treatment of Presbyopia Subjects

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