Pharmacological Treatment of Presbyopia

Near Vision Clinical Trial

Official title:

Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564832
• Other study ID #: IR.SBMU.ORC.REC.1401.005
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR

• Patients with the symptom of blurred vision at near distance

Exclusion Criteria:

Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.

Related Conditions & MeSH terms

• Near Vision
• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hamideh Sabbaghi	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of near vision after one hour following pilocarpine eye drop	The near vision will be measured based on the LogMAR vision at a distance of 33cm before and one hour after instillation of 1.25% pilocarpine eye drop.	baseline to one hour after pilocarpine insillation