Compound to Control Presbyopia Symptoms

NCT05006898 — Phase 1, Completed, 11 participants, Optall Vision

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Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms

Registry	NCT05006898
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	11 (Actual)
Sponsor	Optall Vision (Other)
Conditions	Presbyopia
Interventions	PBO to control presbyopia symptoms (Combination product)
Dates	start 2020-06-01, primary completion 2020-07-01, completion 2020-07-01, first posted 2021-08-16, last updated 2021-08-19
Locations	1 site in Mexico

-Summary

Low dose compose to control presbyopia symptoms

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PBO Investigational drug	Experimental	Combination Product: 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	Active comparator	Combination Product: PBO to control presbyopia symptoms	Pilocarpine was instilled in the other oye.
Brimonidine	Active comparator	Combination Product: PBO to control presbyopia symptoms	Brimonidine was instilled in the other eye.

PBO to control presbyopia symptoms (Combination product), also known as Pilocarpine, Brimonidine, Oxymetazoline: Low dose PBO to control presbyopia symptoms

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 40 Years to 60 Years, 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

+Locations (1)

Facility	City	Country	Status
Optall Vision	Mexico City	Mexico

+Investigators

Cesar Alejandro S Galeana, Principal investigator, Optall Vision