Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms

NCT ID: NCT05006911

Last Updated: 2021-08-17

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

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2021-09-15

Brief Summary

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Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound 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 one hour after binocular instillation.

Conditions

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Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PBOHB

Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients

Group Type EXPERIMENTAL

Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound

Intervention Type DRUG

To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.

Interventions

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Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound

To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.

Intervention Type DRUG

Other Intervention Names

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PBOHB

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Presbyopic
* 40 - 60 years

Exclusion Criteria

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optall Vision

OTHER

Sponsor Role lead

Responsible Party

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Cesar Alejandro Sanchez Galeana

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cesar Alejandro S Galeana, MD

Role: PRINCIPAL_INVESTIGATOR

Optall Vision

Locations

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Optall Vision

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Cesar Alejandro S Galeana, MD

Role: CONTACT

5541851511

Rosario Perez

Role: CONTACT

559199042

Facility Contacts

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Cesar Alejandro S Galeana, MD

Role: primary

5541851511

Other Identifiers

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PBOPC02

Identifier Type: -

Identifier Source: org_study_id

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