Phase 3 Safety Study for the Treatment of Presbyopia Subjects

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

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Presbyopia; Miosis; Near Vision
• Intervention / Treatment: Drug: Aceclidine+Brimonidine combination ophthalmic solution; Drug: Placebo; Drug: Aceclidine Ophthalmic Solution

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Doina Gherghel, MD, PhD, MEd; Phone Number: +447792722412; Email: dgherghel@oraclinical.com
• Study Contact Backup: Name: Marc Odrich, MD; Phone Number: 6462492800; Email: Marc@LENZ-Tx.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Site #326
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Site #302
    • Mesa, Arizona, United States, 85202
      • Site #320
    • Phoenix, Arizona, United States, 85032
      • Site #321
    • Phoenix, Arizona, United States, 85053
      • Site #328
    • Scottsdale, Arizona, United States, 85260
      • Site #338
    • Sun City, Arizona, United States, 85351
      • Site #331
  • California
    • Garden Grove, California, United States, 92843
      • Site #303
    • Glendale, California, United States, 91204
      • Site #313
    • La Jolla, California, United States, 92037
      • Site #334
    • Newport Beach, California, United States, 92663
      • Site #322
    • Petaluma, California, United States, 94954
      • Site #306
    • Rancho Cordova, California, United States, 95670
      • Site #337
    • Santa Barbara, California, United States, 93105
      • Site #304
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Site #308
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Site #316
  • Florida
    • Crystal River, Florida, United States, 32256
      • Site #319
    • Mount Dora, Florida, United States, 32757
      • Site #309
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Site #317
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Site #301
    • Pittsburg, Kansas, United States, 66762
      • Site #307
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Site #324
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Site #336
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Site #330
  • Montana
    • Bozeman, Montana, United States, 59718
      • Site #335
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Site #310
    • W. Fargo, North Dakota, United States, 58078
      • Site #332
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Site #329
    • Powell, Ohio, United States, 43065
      • Site #323
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Site #333
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Site #312
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Site #315
    • Smyrna, Tennessee, United States, 37167
      • Site #311
  • Texas
    • El Paso, Texas, United States, 79902
      • Site #314
    • San Antonio, Texas, United States, 33309
      • Site #327
    • San Antonio, Texas, United States, 78229
      • Site #318

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
5. 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:

1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. 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;
4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally; LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution; Combination ophthalmic solution of Aceclidine and Brimonidine; Other Names: LNZ101
Placebo Comparator: Placebo (Vehicle) ophthalmic solution dosed bilaterally; Placebo: Proprietary Vehicle Ophthalmic Solution	Drug: Placebo; Placebo: Proprietary Vehicle Solution; Other Names: Vehicle
Experimental: Aceclidine ophthalmic solution dosed bilaterally; LNZ 100: Aceclidine ophthalmic solution	Drug: Aceclidine Ophthalmic Solution; Aceclidine; Other Names: LNZ100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.	7 visits over a total duration of approximately 28 weeks

Collaborators and Investigators

• Sponsor: LENZ Therapeutics, Inc
• Collaborators: ORA, Inc.
• Investigators: Study Director: Alisyn Facemire, BA, LENZ Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Eye Drops; Presbyopia; Pharmaceutical Solutions; Opthalmic Solutions; CLARITY; Miotic
• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Miotics; Parasympathomimetics; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions; Aceclidine
• Other Study ID Numbers: 22-150-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No