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

NCT05001243 | Unknown Phase 1 DMC

• 1 other identifier: PBOCP3
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (3)

• Number of eyes improving 3 lines or more near visual acuity

  Eyes instilled with PBOHB

  1 hour

• Eyes improving 3 lines or more near visual acuity

  Eyes instilled with Pilocarpine

  1 hour

• Eyes improving 3 lines or more near VA

  Eyes instilled with Brimonidine

  1 hour

Study Arms (3)

Experimental PBOHB

EXPERIMENTAL

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

Drug: Pilocarpine Hydrochloride; Drug: Brimonidine Tartrate

Pilocarpine 5 mgs

ACTIVE COMPARATOR

Pilocarpine was instilled in the other oye.

Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Brimonidine 0.5 mgs

ACTIVE COMPARATOR

Brimonidine was instilled in the other eye.

Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Interventions

Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac DRUG

PBOHB to improve uncorrected near vision in healthy presbyopic patients

Also known as: PBOHB

Brimonidine 0.5 mgs; Pilocarpine 5 mgs

Pilocarpine Hydrochloride DRUG

Apply in the fellow eye

Also known as: Pil

Experimental PBOHB

Brimonidine Tartrate DRUG

Apply in the fellow eye

Also known as: Brimonidine

Experimental PBOHB

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Optall Vision: lead

Study Sites (1)

Optall Vision

Mexico City, 01090, Mexico

RECRUITING

MeSH Terms

Conditions

Presbyopia

Interventions

Brimonidine Tartrate; Oxymetazoline; Hyaluronic Acid; bromfenac; Pilocarpine; sepharose-4B-polyisoluminol

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Glycosaminoglycans; Polysaccharides; Carbohydrates; Alkaloids

Study Officials

• Cesar Alejandro S Galeana, MD

  Optall Vision

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Alejandro S Galeana, MD

CONTACT

5541851511; optallvision@gmail.com

Rosario S Perez

CONTACT

5591990342; optallvision@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: August 10, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 10, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)