Compound to Control Presbyopia Symptoms

NCT ID: NCT05006898

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-07-01

Brief Summary

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Low dose compose to control presbyopia symptoms

Detailed Description

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A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
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 placebo; Number 2 was designated for the compound

Study Groups

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PBO Investigational drug

Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.

Group Type EXPERIMENTAL

PBO to control presbyopia symptoms

Intervention Type COMBINATION_PRODUCT

Low dose PBO to control presbyopia symptoms

Pilocarpine

Pilocarpine was instilled in the other oye.

Group Type ACTIVE_COMPARATOR

PBO to control presbyopia symptoms

Intervention Type COMBINATION_PRODUCT

Low dose PBO to control presbyopia symptoms

Brimonidine

Brimonidine was instilled in the other eye.

Group Type ACTIVE_COMPARATOR

PBO to control presbyopia symptoms

Intervention Type COMBINATION_PRODUCT

Low dose PBO to control presbyopia symptoms

Interventions

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PBO to control presbyopia symptoms

Low dose PBO to control presbyopia symptoms

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Pilocarpine Brimonidine Oxymetazoline

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

Role: PRINCIPAL_INVESTIGATOR

Optall Vision

Locations

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Optall Vision

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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PBOPC01

Identifier Type: -

Identifier Source: org_study_id

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