Pharmacological Treatment of Presbyopia
Primary Purpose
Near Vision
Status
Recruiting
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pilocarpine 1.25% Eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Near Vision
Eligibility Criteria
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.
Sites / Locations
- Hamideh SabbaghiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilocarpine Therapy
Without Pilocarpine Therapy
Arm Description
The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,
The left eyes of the patients will be defined as the controls.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05564832
First Posted
September 17, 2022
Last Updated
October 1, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05564832
Brief Title
Pharmacological Treatment of Presbyopia
Official Title
Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Near Vision
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilocarpine Therapy
Arm Type
Experimental
Arm Description
The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,
Arm Title
Without Pilocarpine Therapy
Arm Type
No Intervention
Arm Description
The left eyes of the patients will be defined as the controls.
Intervention Type
Drug
Intervention Name(s)
Pilocarpine 1.25% Eye drop
Intervention Description
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.
Primary Outcome Measure Information:
Title
The changes of near vision after one hour following pilocarpine eye drop
Description
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.
Time Frame
baseline to one hour after pilocarpine insillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hamideh Sabbaghi
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi, PhD
Phone
989120285930
Email
sabbaghi.opt@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Pharmacological Treatment of Presbyopia
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