Status:
COMPLETED
A Phase 3 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
This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjective complaints of poor near vision that impact activities of daily living
- Exclusion Criteria
- Uncontrolled systemic disease
- Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll.
- Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications
- Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study
- Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- Participation in a blood or plasma donation program within 30 days prior to study intervention administration
- Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit
- 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
- History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit
- Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy
- Diagnosis of any type of glaucoma or ocular hypertension
- Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled
- Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history
- Females who are pregnant, nursing, or planning a pregnancy during the study
Exclusion
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2020
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT03857542
Start Date
March 1 2019
End Date
September 10 2020
Last Update
December 29 2021
Active Locations (35)
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1
Eye Center South
Dothan, Alabama, United States, 36301
2
M&M Eye Institute
Prescott, Arizona, United States, 86301
3
Walman Eye Center
Sun City, Arizona, United States, 85351
4
Milton M. Hom, OD, FAAO
Azusa, California, United States, 91702