Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients

Study Overview
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Brief Summary
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Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

Detailed Description
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To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation.

Official Title
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Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
* Drug: Pilocarpine Hydrochloride
* Drug: Brimonidine Tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Presbyopic 40 - 59 years Exclusion Criteria: Diabetics Previous eye surgery Previous eye disease > 0.50 myopia > 1.5 hyperopia or astigmatism

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental PBOHB<br>Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. | Drug: Pilocarpine Hydrochloride<br>* Apply in the fellow eye<br>* Other names: Pil;Drug: Brimonidine Tartrate<br>* Apply in the fellow eye<br>* Other names: Brimonidine;|
| Active Comparator: Pilocarpine 5 mgs<br>Pilocarpine was instilled in the other oye. | Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac<br>* PBOHB to improve uncorrected near vision in healthy presbyopic patients<br>* Other names: PBOHB;|
| Active Comparator: Brimonidine 0.5 mgs<br>Brimonidine was instilled in the other eye. | Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac<br>* PBOHB to improve uncorrected near vision in healthy presbyopic patients<br>* Other names: PBOHB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eyes improving 3 lines or more near visual acuity | Eyes instilled with PBOHB | 1 hour | 
| Eyes improving 3 lines or more near visual acuity | Eyes instilled with Pilocarpine | 1 hour | 
| Eyes improving 3 lines or more near VA | Eyes instilled with Brimonidine | 1 hour |