Pilocarpine

Generic Name: Pilocarpine

Brand Names: Betoptic Pilo, Isoptocarpine, Minims Pilocarpine Nitrate, Salagen, Vuity

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₆N_₂O_₂

CAS Number: 92-13-7

Unique Ingredient Identifier: 01MI4Q9DI3

Background: Pilocarpine is a cholinergic muscarinic receptor agonist.

Indication: Pilocarpine oral tablets are indicated for the treatment of dry mouth caused by Sjogren's Syndrome or radiotherapy for cancer of the head and neck.

Pilocarpine ophthalmic formulations are used to treat presbyopia in adults, reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, manage acute angle-closure glaucoma, prevent postoperative elevated IOP associated with laser surgery, and induce miosis.

Associated Conditions: Acute angle-closure glaucoma, Dry Mouth, Glaucoma, Closed-Angle, Increased Intra Ocular Pressure (IOP), Narrow-angle glaucoma, Ocular Hypertension, Open Angle Glaucoma (OAG), Presbyopia, Chronic open-angle glaucoma

Clinical Trials

Evaluation of NV701 (Pilocarpine 1.25%) Compared with Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects with Presbyopia

Early Phase 1

Active, not recruiting

Conditions: Pupil Constriction

Interventions: Drug: NV701
Drug: Pilocarpine 1.25% Eye drop

First Posted Date: 2025-01-20

Last Posted Date: 2025-03-05

Lead Sponsor: Novus Vision LLC

Target Recruit Count: 52

Registration Number: NCT06783686

Locations: 🇺🇸
Arizona Eye Center, Chandler, Arizona, United States
🇺🇸
Global Research Management, Inc, Glendale, California, United States

Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye

Not Applicable

Completed

Conditions: Dry Eye Disease (DED)

Interventions: Drug: Pilocarpine
Drug: artificial tears

First Posted Date: 2024-12-30

Last Posted Date: 2024-12-30

Lead Sponsor: Al-Azhar University

Target Recruit Count: 40

Registration Number: NCT06752278

Locations: 🇪🇬
Al-Azhar university, Damietta, Egypt

Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia

Phase 3

Not yet recruiting

Conditions: Presbyopia

Interventions: Drug: Vehicle
Drug: Pilocarpine HCl Ophthalmic Solution

First Posted Date: 2024-06-11

Last Posted Date: 2024-07-03

Lead Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Target Recruit Count: 330

Registration Number: NCT06451666

Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

Phase 3

Completed

Conditions: Presbyopia

Interventions: Drug: Phentolamine Opthalmic Solution 0.75%
Other: Placebo
Drug: Low dose pilocarpine
Other: Low dose pilocarpine vehicle

First Posted Date: 2022-12-12

Last Posted Date: 2023-11-24

Lead Sponsor: Ocuphire Pharma, Inc.

Target Recruit Count: 333

Registration Number: NCT05646719

Locations: 🇺🇸
Houston, TX, Houston, Texas, United States
🇺🇸
San Antonio, TX, San Antonio, Texas, United States
🇺🇸
Phoenix, AZ, Phoenix, Arizona, United States

and more 23 locations

Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

Phase 4

Withdrawn

Conditions: Presbyopia

Interventions: Drug: AGN-190584

First Posted Date: 2022-11-22

Last Posted Date: 2024-04-09

Lead Sponsor: Gordon Schanzlin New Vision

Registration Number: NCT05624320

Efficacy of Pilocarpine 1% in Presbyopia

Phase 3

Active, not recruiting

Conditions: Presbyopia
Pseudophakia

Interventions: Drug: Pilocarpine Ophthalmic

First Posted Date: 2022-10-13

Last Posted Date: 2022-10-13

Lead Sponsor: Isfahan University of Medical Sciences

Target Recruit Count: 25

Registration Number: NCT05578001

Locations: 🇮🇷
Isfahan Eye Research Center, Isfahan, Iran, Islamic Republic of

Pharmacological Treatment of Presbyopia

Early Phase 1

Recruiting

Conditions: Near Vision

Interventions: Drug: Pilocarpine 1.25% Eye drop

First Posted Date: 2022-10-04

Last Posted Date: 2022-10-04

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Target Recruit Count: 75

Registration Number: NCT05564832

Locations: 🇮🇷
Hamideh Sabbaghi, Tehran, Iran, Islamic Republic of

Xerostomia in Patients With a Life-limiting Condition or Frailty

Phase 3

Not yet recruiting

Conditions: Xerostomia
Dry Mouth

Interventions: Other: Placebo
Drug: Pilocarpine

First Posted Date: 2022-08-18

Last Posted Date: 2022-08-18

Lead Sponsor: Maastricht University Medical Center

Target Recruit Count: 120

Registration Number: NCT05506137

Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia

Phase 2

Withdrawn

Conditions: Presbyopia

Interventions: Drug: Vehicle
Drug: AGN-190584

First Posted Date: 2022-05-26

Last Posted Date: 2022-06-29

Lead Sponsor: Allergan

Registration Number: NCT05393089

Locations: 🇺🇸
Global Research Management /ID# 243544, Glendale, California, United States
🇺🇸
United Medical Research Institute /ID# 243531, Inglewood, California, United States
🇺🇸
Salvay Vision /ID# 243828, Newport Beach, California, United States

and more 29 locations

Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

Phase 2

Completed

Conditions: Presbyopia

Interventions: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2
Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3
Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1
Drug: Placebo Ophthalmic Topical Cream

First Posted Date: 2021-11-17

Last Posted Date: 2023-09-01

Lead Sponsor: Glaukos Corporation

Target Recruit Count: 123

Registration Number: NCT05124275

Locations: 🇺🇸
Glaukos Investigator, San Antonio, Texas, United States

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