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

NCT05006911 — Phase 1, Unknown, 11 participants, Optall Vision

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Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia

Registry	NCT05006911, acronym PBO
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	11 (Estimated)
Sponsor	Optall Vision (Other)
Conditions	Presbyopia
Interventions	Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound (Drug)
Dates	start 2021-08-14, primary completion 2021-09-01 (estimated), completion 2021-09-15 (estimated), first posted 2021-08-16, last updated 2021-08-17
Locations	1 site in Mexico

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PBOHB	Experimental	Drug: 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

Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound (Drug), also known as PBOHB: To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.

+Outcome measures

Primary outcomes

Jaeger near uncorrected visual acuity improvement [1 hour]: Measure uncorrected near vision change after binocular instillation of PBOHB compound

+Eligibility

Sex: All, ages: 40 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy
* Presbyopic
* 40 - 60 years

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Optall Vision	Mexico City	Mexico	Recruiting

+Investigators

Cesar Alejandro S Galeana, MD, Principal investigator, Optall Vision