GEMINI 1
Trial question
What is the role of pilocarpine hydrochloride ophthalmic solution in patients with presbyopia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
73.0% female
27.0% male
N = 323
323 patients (235 female, 88 male).
Inclusion criteria: patients aged 40-55 years with presbyopia.
Key exclusion criteria: severe dry eye disease; history of intraocular surgery; history of glaucoma or ocular hypertension; anisocoria of > 1 mm between pupils under mesopic conditions.
Interventions
N=163 pilocarpine hydrochloride (one drop of pilocarpine hydrochloride 1.25% in each eye, once daily, for up to 30 days).
N=160 placebo (one drop of vehicle in each eye, once daily, for up to 30 days).
Primary outcome
Proportion of patients with improved mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 3 on day 30
30.7%
8.1%
30.7 %
23.0 %
15.3 %
7.7 %
0.0 %
Pilocarpine
hydrochloride
Placebo
Significant
increase ▲
NNT = 4
Significant increase in the proportion of patients with improved mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 3 on day 30 (30.7% vs. 8.1%; AD 22.5%, 95% CI 14.3 to 30.8).
Secondary outcomes
Significant increase in the proportion of patients with improved mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 6 on day 30 (18.4% vs. 8.8%; AD 9.7%, 95% CI 2.3 to 17).
Significant increase in the proportion of patients who achieved 20/40 or better photopic, high-contrast, binocular distance-corrected near visual acuity at hour 1 on day 30 (92.5% vs. 73.9%; AD 18.7%, 95% CI 10.6 to 26.7).
Significantly greater improvement of mean mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 0.5 on day 30 (9.3 vs. 4.2; MD 5.1, 95% CI 3.7 to 6.5).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients aged 40-55 years with presbyopia, pilocarpine hydrochloride was superior to placebo with respect to the proportion of patients with improved mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 3 on day 30.
Reference
George O Waring th, Francis W Price Jr, David Wirta et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371.
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