Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

Study Overview
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Brief Summary
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Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.

Official Title
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A Phase 3 Study of the Safety and Efficacy of 2% Pilocarpine Ophthalmic Spray Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser
* Combination Product: Placebo administered with the Optejet dispenser


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Poor near vision impacting daily living that requires near correction Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive In need of near addition power < +2.00 D to achieve BCNVA of 0.0 logMAR Primary Exclusion Criteria: Diagnosis of glaucoma or ocular hypertension Narrow iridocorneal angles History of intraocular surgery, refractive surgery, laser treatment, or iris surgery Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris Presence/history of a severe/serious ocular condition or any other unstable medical condition Presence or history of manifest strabismus, amblyopia, or nystagmus Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears Clinically significant external ocular inflammation within 30 days of Screening Visit Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit Known pilocarpine allergy or contraindication to use of pilocarpine Presence or history of congenital heart anomaly, valve disease, or other cardiac disease Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilocarpine 2% Ophthalmic Spray<br>2% pilocarpine ophthalmic spray administered with the Optejet dispenser | Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser<br>* Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser<br>* Other names: MicroLine;|
| Placebo Comparator: Placebo Spray<br>Placebo ophthalmic spray administered with the Optejet dispenser | Combination Product: Placebo administered with the Optejet dispenser<br>* Vehicle ophthalmic solution administered with the Optejet dispenser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA) | The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline. | 120 minutes post-dosing |