Phase 3 Efficacy Study of AGN-190584 in Participants With Presbyopia

• Status: Completed
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the efficacy, safety, and pharmacokinetics of AGN-190584 when administered bilaterally, once daily for 30 days in participants with presbyopia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

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