Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia (GEMINI 1)

Allergan

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Drug: Pilocarpine HCl Ophthalmic Solution; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03804268

1883-301-013

Details and patient eligibility

About

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.

Enrollment: 323 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjective complaints of poor near vision that impact activities of daily living

Exclusion criteria

• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
• Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
• Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
• Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
• Diagnosis of any type of glaucoma or ocular hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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323 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Participants received one drop of vehicle in each eye, once daily, for up to 30 days.

Treatment:

Other: Vehicle

Pilocarpine HCl Ophthalmic Solution

Experimental group

Description:

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Treatment:

Drug: Pilocarpine HCl Ophthalmic Solution