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

NCT ID: NCT05001243

Last Updated: 2021-08-19

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

2021-08-10

Study Completion Date

2021-09-10

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.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
While in office the care provider took a number out of a closed container. Number 1 was designated for the Brimonidine, Number 2 was designated for the PBOHB compound, Number 3 was designated for de Pilocarpine compound

Study Groups

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Experimental PBOHB

Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.

Group Type EXPERIMENTAL

Pilocarpine Hydrochloride

Intervention Type DRUG

Apply in the fellow eye

Brimonidine Tartrate

Intervention Type DRUG

Apply in the fellow eye

Pilocarpine 5 mgs

Pilocarpine was instilled in the other oye.

Group Type ACTIVE_COMPARATOR

Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Intervention Type DRUG

PBOHB to improve uncorrected near vision in healthy presbyopic patients

Brimonidine 0.5 mgs

Brimonidine was instilled in the other eye.

Group Type ACTIVE_COMPARATOR

Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Intervention Type DRUG

PBOHB to improve uncorrected near vision in healthy presbyopic patients

Interventions

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Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

PBOHB to improve uncorrected near vision in healthy presbyopic patients

Intervention Type DRUG

Pilocarpine Hydrochloride

Apply in the fellow eye

Intervention Type DRUG

Brimonidine Tartrate

Apply in the fellow eye

Intervention Type DRUG

Other Intervention Names

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PBOHB Pil Brimonidine

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
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 S Perez

Role: CONTACT

5591990342

Facility Contacts

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Cesar Alejandro S Galeana, MD

Role: primary

5541851511

Other Identifiers

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PBOCP3

Identifier Type: -

Identifier Source: org_study_id

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