Compound to Control Presbyopia Symptoms

Phase 1

Completed

• Conditions: Presbyopia
• Interventions: Combination Product: PBO to control presbyopia symptoms

• Registration Number: NCT05006898
• Lead Sponsor: Optall Vision

Brief Summary

Low dose compose to control presbyopia symptoms

Detailed Description

A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Study First Submitted: 2021-06-09
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-14
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

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

Inclusion Criteria

• healthy
• Presbyopic
• 40 - 59 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine	PBO to control presbyopia symptoms	Brimonidine was instilled in the other eye.
PBO Investigational drug	PBO to control presbyopia symptoms	Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Pilocarpine	PBO to control presbyopia symptoms	Pilocarpine was instilled in the other oye.

Primary Outcome Measures

Name	Time	Method
Jaeger notation near uncorrected visual acuity change	1 hour	Number of lines improved 1 hour after drug instillation
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone	1 hour	Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine

Trial Locations

Locations (1)

Optall Vision; 🇲🇽 Mexico City, Mexico