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

Optall Vision

Status and phase

Unknown

Phase 1

Conditions

Presbyopia

Treatments

Drug: Brimonidine Tartrate

Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Drug: Pilocarpine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT05001243

PBOCP3

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy
Presbyopic
40 - 59 years

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

11 participants in 3 patient groups

Experimental PBOHB

Experimental group

Description:

Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.

Treatment:

Drug: Pilocarpine Hydrochloride

Drug: Brimonidine Tartrate

Pilocarpine 5 mgs

Active Comparator group

Description:

Pilocarpine was instilled in the other oye.

Treatment:

Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac

Brimonidine 0.5 mgs

Active Comparator group

Description: