Study Results
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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UNKNOWN
EARLY_PHASE1
75 participants
INTERVENTIONAL
2022-08-01
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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,
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.
Without Pilocarpine Therapy
The left eyes of the patients will be defined as the controls.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with the symptom of blurred vision at near distance
Exclusion Criteria
40 Years
60 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Hamideh Sabbaghi
Assistant Professor
Locations
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Hamideh Sabbaghi
Tehran, , Iran
Countries
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Facility Contacts
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Other Identifiers
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IR.SBMU.ORC.REC.1401.005
Identifier Type: -
Identifier Source: org_study_id
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