NCT05564832

Pharmacological Treatment of Presbyopia

Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.

Conditions

• Near Vision

Interventions

Type	Name	Description
DRUG	Pilocarpine 1.25% Eye drop	One millimeter of pilocarpine eye drop (Bakhtarbiochemistry Company, Iran) contains pilocarpine hydrochloride 1.25% (12.5 mg) as an active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. The medication preservative is 0.0075% benzalkonium chloride. Inactive ingredients in the ophthalmic are boric acid, sodium citrate dihydrate, sodium chloride, purified water. Another pilocarpine eye drop was Vuity® (1.25% pilocarpine; Allergan company) contains the active intergradients of pilocarpine hydrochloride 1.25% (12.5 mg/mL), equivalent to 1.06% (10.6 mg/mL) pilocarpine free-base and the preservative agents was 0.0075% benzalkonium chloride.

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2022-10-04
• Last updated: 2022-10-04

Locations

1 site across 1 country: Iran