Pharmacological Treatment of Presbyopia

NCT05564832 | Unknown Early Phase 1

• 1 other identifier: IR.SBMU.ORC.REC.1401.005
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Near Vision

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pilocarpine Therapy

EXPERIMENTAL

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

Without Pilocarpine Therapy

NO INTERVENTION

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

Interventions

Pilocarpine 1.25% Eye drop DRUG

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.

Pilocarpine Therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
• Patients with the symptom of blurred vision at near distance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Hamideh Sabbaghi

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Pilocarpine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: October 4, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

IR (1)