Status:
COMPLETED
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Lead Sponsor:
Allergan
Conditions:
Presbyopia
Eligibility:
All Genders
40-55 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- \- Subjective complaints of poor near vision that impact activities of daily living
Exclusion
- 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT03804268
Start Date
December 21 2018
End Date
October 31 2019
Last Update
December 28 2021
Active Locations (36)
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1
Arizona Eye Center
Chandler, Arizona, United States, 85224
2
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
3
Assil Eye Institute
Beverly Hills, California, United States, 90210
4
American Institute of Research
Los Angeles, California, United States, 90017