A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily (Virgo)

Allergan

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Drug: Pilocarpine HCl; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04983589

M21-195

Details and patient eligibility

About

Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo).

AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States.

Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.

Enrollment: 230 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Objective and subjective evidence of presbyopia.

Exclusion criteria

• 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.
• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.

Treatment:

Drug: Vehicle

AGN-190584

Experimental group

Description:

AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.

Treatment:

Drug: Pilocarpine HCl