Compound to Control Presbyopia Symptoms

NCT05006898 | Completed Phase 1 DMC

• 1 other identifier: PBOPC01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Low dose compose to control presbyopia symptoms

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• Jaeger notation near uncorrected visual acuity change

  Number of lines improved 1 hour after drug instillation

  1 hour

• Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone

  Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine

  1 hour

Study Arms (3)

PBO Investigational drug

EXPERIMENTAL

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

Combination Product: PBO to control presbyopia symptoms

Pilocarpine

ACTIVE COMPARATOR

Pilocarpine was instilled in the other oye.

Combination Product: PBO to control presbyopia symptoms

Brimonidine

ACTIVE COMPARATOR

Brimonidine was instilled in the other eye.

Combination Product: PBO to control presbyopia symptoms

Interventions

PBO to control presbyopia symptoms COMBINATION_PRODUCT

Low dose PBO to control presbyopia symptoms

Also known as: Pilocarpine, Brimonidine, Oxymetazoline

Brimonidine; PBO Investigational drug; Pilocarpine

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

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Pilocarpine; Brimonidine Tartrate; Oxymetazoline

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Cesar Alejandro S Galeana

  Optall Vision

  PRINCIPAL INVESTIGATOR

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 placebo; Number 2 was designated for the compound
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: August 16, 2021
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)