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

Sponsor

Alisyn Facemire (Other)

Overall Status

Recruiting

CT.gov ID

NCT05431543

Collaborator

ORA, Inc. (Industry)

Enrollment

Locations

Arms

1.8

Anticipated Duration (Months)

Patients Per Site

8.2

Patients Per Site Per Month

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
Presbyopia Refractive Errors Eye Diseases Near Vision Miosis	Drug: Aceclidine+Brimonidine combination ophthalmic solution Drug: Aceclidine ophthalmic solution Drug: Vehicle proprietary ophthalmic solution	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 6, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally LENZ 101: Aceclidine/Brimonidine combination ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution LNZ101-combination ophthalmic solution Other Names: LNZ101 Brimonidine Aceclidine Vehicle Drug: Vehicle proprietary ophthalmic solution Proprietary vehicle ophthalmic solution Other Names: vehicle
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally LENZ 100: Aceclidine ophthalmic solution	Drug: Aceclidine ophthalmic solution Aceclidine alone + vehicle Other Names: LNZ100 Aceclidine Vehicle Drug: Vehicle proprietary ophthalmic solution Proprietary vehicle ophthalmic solution Other Names: vehicle
Experimental: Vehicle Ophthalmic Solution dosed bilaterally Proprietary vehicle ophthalmic solution	Drug: Vehicle proprietary ophthalmic solution Proprietary vehicle ophthalmic solution Other Names: vehicle

Arm

Intervention/Treatment

Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally

LENZ 101: Aceclidine/Brimonidine combination ophthalmic solution

Drug: Aceclidine+Brimonidine combination ophthalmic solution

LNZ101-combination ophthalmic solution

Other Names:

LNZ101

Brimonidine

Aceclidine

Vehicle

Drug: Vehicle proprietary ophthalmic solution

Proprietary vehicle ophthalmic solution

Other Names:

vehicle

Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

LENZ 100: Aceclidine ophthalmic solution

Drug: Aceclidine ophthalmic solution

Aceclidine alone + vehicle

Other Names:

LNZ100

Aceclidine

Vehicle

Drug: Vehicle proprietary ophthalmic solution

Proprietary vehicle ophthalmic solution

Other Names:

vehicle

Experimental: Vehicle Ophthalmic Solution dosed bilaterally

Proprietary vehicle ophthalmic solution

Drug: Vehicle proprietary ophthalmic solution

Proprietary vehicle ophthalmic solution

Other Names:

vehicle

Outcome Measures

Primary Outcome Measures

Primary Efficacy Variable [1 hour post treatment]
Percentage of subjects with at least a 3-line improvement in near visual acuity in the study eye.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INSIGHT Study Site #4	Glendale	California	United States	91204
2	INSIGHT Study Site #1	Andover	Massachusetts	United States	01810
3	INSIGHT Study Site #2	Memphis	Tennessee	United States	38119
4	INSIGHT Study Site #5	Houston	Texas	United States	77027