A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT03857542 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pilocarpine HCl Ophthalmic Solution (Drug); Vehicle (Other)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction at Day 30, Hour 3 |
10.8; 26.0 | <.0001 sig |
| SECONDARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA at Day 30, Hour 6 |
9.9; 16.3 | 0.0548 |
| SECONDARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 |
8.6; 14.5 | 0.0693 |
| SECONDARY Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 |
4.7; 8.8 | <.0001 sig |
| SECONDARY Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular DCNVA at Day 30, Hour 1 |
82.8; 92.7 | 0.0141 sig |
| SECONDARY Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3 |
0.5; 1.3 | <.0001 sig |
| SECONDARY Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3 |
2.9; 6.4 | <.0001 sig |
| SECONDARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 |
8.7; 12.6 | 0.2200 |
| SECONDARY Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25 |
3.9; 6.5 | <.0001 sig |
| SECONDARY Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3 |
77.8; 90.2 | 0.0141 sig |
| SECONDARY Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3 |
0.5; 1.2 | <.0001 sig |
| SECONDARY Mean Change From Baseline in Presbyopia Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3 |
-0.5; -0.9 | 0.0002 sig |
| SECONDARY Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3 |
-0.4; -0.7 | 0.0002 sig |
Summary
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03857542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.