Pharmacological Treatment of Presbyopia

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05564832

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Near Vision	Drug: Pilocarpine 1.25% Eye drop	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilocarpine Therapy The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,	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.
No Intervention: Without Pilocarpine Therapy The left eyes of the patients will be defined as the controls.

Arm

Intervention/Treatment

Experimental: Pilocarpine Therapy

The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,

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.

No Intervention: Without Pilocarpine Therapy

The left eyes of the patients will be defined as the controls.

Outcome Measures

Primary Outcome Measures

The changes of near vision after one hour following pilocarpine eye drop [baseline to one hour after pilocarpine insillation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamideh Sabbaghi	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamideh Sabbaghi, Assistant Professor, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05564832

Other Study ID Numbers:

IR.SBMU.ORC.REC.1401.005

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Presbyopia

Ophthalmic Solutions

Pilocarpine

Study Results

No Results Posted as of Oct 4, 2022