Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
The primary efficacy variable in this INSIGHT study is the percentage of subjects with at least a 3-line improvement.
The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater improvement from pre-treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally Aceclidine/Brimonidine combination ophthalmic solution |
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Aceclidine ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Vehicle Proprietary Ophthalmic Solution
Ophthalmic Solution
Other Names:
|
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally Aceclidine ophthalmic solution |
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Aceclidine ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Vehicle Proprietary Ophthalmic Solution
Ophthalmic Solution
Other Names:
|
Experimental: Vehicle Ophthalmic Solution dosed bilaterally Proprietary Vehicle ophthalmic solution |
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Aceclidine ophthalmic solution
Ophthalmic Solution
Other Names:
Drug: Vehicle Proprietary Ophthalmic Solution
Ophthalmic Solution
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With at Least a 3-line Improvement in Near Visual Acuity in the Study Eye [1 hour]
The percentage of subjects with at least a 3-line improvement from the pre-dose Aceclidine/Brimonidine (LNZ101) arm versus the vehicle arm, and the Aceclidine arm (LNZ100) versus the vehicle arm.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects MUST:
-
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 SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
-
Have up to 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:
Subjects must NOT:
-
Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
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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 determined by total corneal fluorescein staining at Visit 1;
-
Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | INSIGHT Study Site #4 | Glendale | California | United States | 91204 |
2 | INSIGHT Study Site #3 | Indianapolis | Indiana | United States | 46240 |
3 | INSIGHT Study Site #1 | Andover | Massachusetts | United States | 01810 |
4 | INSIGHT Study Site #2 | Memphis | Tennessee | United States | 38119 |
5 | INSIGHT Study Site #5 | Houston | Texas | United States | 77027 |
Sponsors and Collaborators
- LENZ Therapeutics, Inc
- ORA, Inc.
Investigators
- Study Director: Alisyn Facemire, LENZ Therapeutics, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-100-0007