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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05001243

Acronym

PBOHB

Enrollment

Registered

2021-08-11

Start date

2021-08-10

Completion date

2021-09-10

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Brief summary

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

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.

Interventions

DRUGCompound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

PBOHB to improve uncorrected near vision in healthy presbyopic patients

DRUGPilocarpine Hydrochloride

Apply in the fellow eye

DRUGBrimonidine Tartrate

Apply in the fellow eye

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

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

Intervention 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

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Presbyopic * 40 - 59 years

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Mexico

Contacts

Primary ContactCesar Alejandro S Galeana, MD

optallvision@gmail.com5541851511

Backup ContactRosario S Perez

optallvision@gmail.com5591990342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026