Pharmacological Treatment of Presbyopia

NCT ID: NCT05564832

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Near Vision

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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,

Group Type EXPERIMENTAL

Pilocarpine 1.25% Eye drop

Intervention Type 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.

Without Pilocarpine Therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamideh Sabbaghi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hamideh Sabbaghi

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Facility Contacts

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Hamideh Sabbaghi, PhD

Role: primary

989120285930

Other Identifiers

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IR.SBMU.ORC.REC.1401.005

Identifier Type: -

Identifier Source: org_study_id

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