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

Phase 1

• Conditions: Presbyopia
• Interventions: Drug: Pilocarpine Hydrochloride; Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac; Drug: Brimonidine Tartrate

• Registration Number: NCT05001243
• Lead Sponsor: Optall Vision

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.

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 compared to Pilocarpine and Brimonidine one hour after binocular instillation.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study Start: 2021-08-10
• Study First Posted: 2021-08-11
• Last Update Submitted: 2021-08-14
• Last Update Posted: 2021-08-19
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• 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
Experimental PBOHB	Pilocarpine Hydrochloride	Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Brimonidine 0.5 mgs	Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac	Brimonidine was instilled in the other eye.
Pilocarpine 5 mgs	Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac	Pilocarpine was instilled in the other oye.
Experimental PBOHB	Brimonidine Tartrate	Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.

Primary Outcome Measures

Name	Time	Method
Eyes improving 3 lines or more near visual acuity	1 hour	Eyes instilled with Pilocarpine
Number of eyes improving 3 lines or more near visual acuity	1 hour	Eyes instilled with PBOHB
Eyes improving 3 lines or more near VA	1 hour	Eyes instilled with Brimonidine

Trial Locations

Locations (1)

Optall Vision; 🇲🇽 Mexico City, Mexico