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

Phase 1

• Conditions: Presbyopia
• Interventions: Drug: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound

• Registration Number: NCT05006911
• Lead Sponsor: Optall Vision

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.

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 Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-12
• Study Start: 2021-08-14
• Last Update Submitted: 2021-08-14
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-17
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Healthy
• Presbyopic
• 40 - 60 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PBOHB	Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound	Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients

Primary Outcome Measures

Name	Time	Method
Jaeger near uncorrected visual acuity improvement	1 hour	Measure uncorrected near vision change after binocular instillation of PBOHB compound

Trial Locations

Locations (1)

Optall Vision; 🇲🇽 Mexico City, Mexico