Twice-daily pilocarpine HCl safe, effective in treating presbyopia
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Key takeaways:
- A greater proportion of participants in the twice-daily pilocarpine HCl group had near-vision improvements.
- The most common adverse event was headache, which was reported in 8.8% of the pilocarpine group.
Pilocarpine hydrochloride 1.25% administered twice daily yielded statistically greater near-vision improvements than a control vehicle, while maintaining the safety profile of once-daily administration, according to research.
“In this randomized, vehicle-controlled, double-masked, parallel-group, phase 3 study, the primary and secondary endpoints demonstrated statistically significantly greater improvements in near vision with pilocarpine HCl 1.25% twice daily than with vehicle, without compromising distance acuity,” Shane Kannarr, OD, from Kannarr Eye Care in Pittsburg, Kansas, and colleagues wrote in the American Journal of Ophthalmology.
Image: Adobe Stock.
To investigate the safety, efficacy and pharmacokinetics of twice-daily pilocarpine hydrochloride 1.25% vs. control vehicle, researchers enrolled 230 individuals aged 40 to 55 years with evidence of presbyopia. Participants were instructed to administer drops in both eyes 6 hours apart for 14 days.
Kannarr and colleagues examined the proportion of participants that gained three or more lines in mesopic and photopic, high-contrast, binocular distance-corrected near visual acuity on day 14, 3 hours following the second dose, with no more than a five-letter loss in mesopic/photopic corrected distance visual acuity with the same refractive correction. Researchers also monitored participants for treatment-emergent adverse events.
According to results, a significantly higher proportion of participants in the pilocarpine group achieved both primary and secondary efficacy endpoints than in the vehicle group, with a between treatment difference of 27.3% (P < .01) and 26.4% (P < .01), respectively.
The most common adverse response was headache, which was reported in 8.8% of the pilocarpine group and 3.4% of the vehicle group.
“In summary, the primary and secondary endpoints of this study demonstrated statistically significantly greater improvements in near vision with pilocarpine HCl 1.25% twice daily than with vehicle, without compromising distance acuity,” Kannarr and colleagues wrote. “Moreover, systemic accumulation was minimal, and the safety profile of pilocarpine HCl 1.25% twice daily was consistent with that of pilocarpine HCl 1.25% once daily.”
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