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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental PBOHB | Experimental | Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. |
|
| Pilocarpine 5 mgs | Active Comparator | Pilocarpine was instilled in the other oye. |
|
| Brimonidine 0.5 mgs | Active Comparator | Brimonidine was instilled in the other eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac | Drug | PBOHB to improve uncorrected near vision in healthy presbyopic patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of eyes improving 3 lines or more near visual acuity | Eyes instilled with PBOHB | 1 hour |
| Eyes improving 3 lines or more near visual acuity | Eyes instilled with Pilocarpine | 1 hour |
| Eyes improving 3 lines or more near VA | Eyes instilled with Brimonidine | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesar Alejandro S Galeana, MD | Contact | 5541851511 | optallvision@gmail.com | |
| Rosario S Perez | Contact | 5591990342 | optallvision@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cesar Alejandro S Galeana, MD | Optall Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optall Vision | Recruiting | Mexico City | 01090 | Mexico |
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Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
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While in office the care provider took a number out of a closed container. Number 1 was designated for the Brimonidine, Number 2 was designated for the PBOHB compound, Number 3 was designated for de Pilocarpine compound
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| Pilocarpine Hydrochloride | Drug | Apply in the fellow eye |
|
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| Brimonidine Tartrate | Drug | Apply in the fellow eye |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D010109 | Oxymetazoline |
| D006820 | Hyaluronic Acid |
| C053083 | bromfenac |
| D010862 | Pilocarpine |
| C027239 | sepharose-4B-polyisoluminol |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000470 | Alkaloids |
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