Phase 3
Completed N=323
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Source: ClinicalTrials.gov NCT03804268 ↗Enrolled (actual)
323
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 — 8.1; 30.7 percentage of participants — p=<0.0001
◆ Published Evidence
Established
49citations · ~12 / year
Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial.
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 with presbyopia.
Linked Publications (3)
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Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial.
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Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2).
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Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 |
8.1; 30.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6 |
8.8; 18.4 | 0.0114 sig |
| SECONDARY Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 |
8.5; 10.6 | 1.0000 |
| SECONDARY Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 |
4.2; 9.3 | 0.0114 sig |
| SECONDARY Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1 |
73.9; 92.5 | 0.0114 sig |
| SECONDARY Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3 |
0.6; 1.4 | 0.0114 sig |
| SECONDARY Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3 |
3.1; 6.6 | 0.0114 sig |
| SECONDARY Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 |
8.6; 7.5 | 1.0000 |
| SECONDARY Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25 |
3.7; 6.3 | 0.0114 sig |
| SECONDARY Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3 |
71.9; 84.5 | 0.0171 sig |
| SECONDARY Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3 |
0.6; 1.4 | 0.0114 sig |
| SECONDARY Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3 |
-0.5; -1.0 | 0.0114 sig |
| SECONDARY Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3 |
-0.4; -0.7 | 0.0114 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03804268) and the linked publication. 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. Informational only — not medical advice.