Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

Corxel Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Presbyopia; Eye Diseases; Miosis; Near Vision

Treatments: Drug: Aceclidine ophthalmic solution; Drug: Placebo (Vehicle) ophthalmic solution; Drug: Aceclidine+Brimonidine combination ophthalmic solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06045299

CTR20232913 (Other Identifier)

JX07001

Details and patient eligibility

About

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

Full description

A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.

Enrollment: 300 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be able and willing to provide written informed consent 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 at Visit 1;
4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder in both eyes determined by manifest refraction documented at Visit 1;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1.
7. Be presbyopic as determined at Visit 2 baseline

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 or at Visit 2 (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;
4. Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

LNZ101 (Aceclidine/Brimonidine) ophthalmic solution

Experimental group

Description:

Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.

Treatment:

Drug: Aceclidine+Brimonidine combination ophthalmic solution

LNZ100 (Aceclidine) ophthalmic solution

Experimental group

Description:

Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.

Treatment:

Drug: Aceclidine ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Placebo Comparator group

Description:

Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.

Treatment:

Drug: Placebo (Vehicle) ophthalmic solution