NCT05006911

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

August 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

18 days

First QC Date

August 4, 2021

Last Update Submit

August 14, 2021

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Jaeger near uncorrected visual acuity improvement

    Measure uncorrected near vision change after binocular instillation of PBOHB compound

    1 hour

Study Arms (1)

PBOHB

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: PBOHB
PBOHB

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Presbyopic
  • years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optall Vision

Mexico City, 01090, Mexico

RECRUITING

MeSH Terms

Conditions

Presbyopia

Interventions

PilocarpineBrimonidine TartrateOxymetazolineHyaluronic Acidbromfenac

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingImidazolesAzolesHeterocyclic Compounds, 1-RingGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Cesar Alejandro S Galeana, MD

    Optall Vision

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Alejandro S Galeana, MD

CONTACT

5541851511optallvision@gmail.com

Rosario Perez

CONTACT

559199042optallvision@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 16, 2021

Study Start

August 14, 2021

Primary Completion

September 1, 2021

Study Completion

September 15, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)