Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination ophthalmic solution (LNZ101) dosed bilaterally | Experimental | LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution |
|
| Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally | Experimental | LNZ 100: Aceclidine ophthalmic solution |
|
| Vehicle Ophthalmic Solution dosed bilaterally | Experimental | Proprietary vehicle ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aceclidine+Brimonidine combination ophthalmic solution | Drug | LNZ101-combination ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision | 1 hour post treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alisyn Facemire, BA | LENZ Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSIGHT-2 Study Site #5 | Chandler | Arizona | 85224 | United States | ||
| INSIGHT-2 Study Site #3 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Sequence 1 (123) | LNZ101 (1), LNZ100 (2), Vehicle (3) |
| FG001 | Crossover Sequence 2 (231) | LNZ100 (2), Vehicle (3), LNZ101 (1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2022 | Aug 14, 2024 |
Not provided
Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Not provided
Not provided
Not provided
| Aceclidine ophthalmic solution | Drug | LNZ100- aceclidine ophthalmic solution |
|
|
| Vehicle proprietary ophthalmic solution | Drug | Proprietary Vehicle ophthalmic solution |
|
|
| Glendale |
| California |
| 91204 |
| United States |
| INSIGHT-2 Study Site #1 | Andover | Massachusetts | 01810 | United States |
| INSIGHT-2 Study Site #2 | Memphis | Tennessee | 38119 | United States |
| INSIGHT-2 Study Site #4 | Houston | Texas | 77027 | United States |
| FG002 | Crossover Sequence 3 (312) | Vehicle (3), LNZ101 (1), LNZ100 (2) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Sequence 1 (123) | LNZ101 (1), LNZ100 (2), Vehicle (3) |
| BG001 | Crossover Sequence 2 (231) | LNZ100 (2), Vehicle (3), LNZ101 (1) |
| BG002 | Crossover Sequence 3 (312) | Vehicle (3), LNZ101 (1), LNZ100 (2) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision | The treatment crossover design allowed for each treatment to be analyzed in all subjects. The primary efficacy analysis was performed on a mITT population of subjects meeting the baseline criteria. | Posted | Number | percentage of participants | 1 hour post treatment |
|
|
|
|
Approximately 3 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LNZ101 | LNZ101 (aceclidine hydrochloride and brimonidine tartrate) (non-preserved) Ophthalmic Solution | 0 | 59 | 0 | 59 | 17 | 59 |
| EG001 | LNZ100 | LNZ100 (Aceclidine hydrochloride) (non-preserved) Ophthalmic solution | 0 | 58 | 0 | 58 | 3 | 58 |
| EG002 | Vehicle Ophthalmic Solution | Proprietary vehicle ophthalmic solution | 0 | 58 | 0 | 58 | 0 | 58 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Instillation Site Pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ocular Instillation Site Pruritus | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Non-Ocular Headaches | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Odrich, MD | LENZ Therapeutics, Inc. | (646) 249-2800 | marc@lenz-tx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2023 | Aug 14, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D009216 | Myopia |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| C084650 | aceclidine |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio (OR) |
| 102.093 |
| 2-Sided |
| Superiority |