Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms

• Sponsor: Optall Vision (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05006911
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 1.1
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound	Phase 1

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 one hour after binocular instillation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patientsTo determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia
• Actual Study Start Date: Aug 14, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PBOHB 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; To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.; Other Names: PBOHB

Outcome Measures

Primary Outcome Measures

1. Jaeger near uncorrected visual acuity improvement [1 hour]

   Measure uncorrected near vision change after binocular instillation of PBOHB compound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Presbyopic

• 40 - 60 years

Exclusion Criteria:

• Diabetics

• Previous eye surgery

• Previous eye disease

• 0.50 myopia

• 1.5 hyperopia or astigmatism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optall Vision	Mexico City		Mexico	01090

Sponsors and Collaborators

• Optall Vision

Investigators

• Principal Investigator: Cesar Alejandro S Galeana, MD, Optall Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cesar Alejandro Sanchez Galeana, Principal Investigator, Optall Vision
• ClinicalTrials.gov Identifier: NCT05006911
• Other Study ID Numbers: PBOPC02
• First Posted: Aug 16, 2021
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Presbyopia; Bromfenac; Brimonidine Tartrate; Phenylephrine; Oxymetazoline; Hyaluronic Acid; Pilocarpine

Study Results

No Results Posted as of Aug 17, 2021