Olopatadine

Generic Name: Olopatadine

Brand Names: Pataday, Patanase, Patanol, Pazeo, Ryaltris, Opatanol

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₃NO_₃

CAS Number: 113806-05-6

Unique Ingredient Identifier: D27V6190PM

Background: Olopatadine is a selective histamine H1 antagonist and mast cell stabilizer that works by attenuating inflammatory and allergic reactions. It is a structural analog of doxepin, which has a minimal anti-allergic activity. Olopatadine works by blocking the effects of histamine, which is a primary inflammatory mediator that causes inflammatory and allergic reactions. An ophthalmic solution of olopatadine was approved by the FDA and European Union for the treatment of seasonal and perennial allergic conjunctivitis in 1996 and 2002, respectively. In comparison to other anti-allergenic ophthalmic medications, olopatadine displays a good comfort and tolerability profile since it does not cause perturbation of cell membranes. Olopatadine is used for the symptomatic treatment of ocular itching associated with allergic conjunctivitis in ophthalmic formulations and seasonal allergic rhinitis in intranasal formulations. It is currently marketed under several brand names, including Pazeo, Patanase, and Opatanol.

Indication: Olopatadine is indicated for the symptomatic treatment of ocular itching associated with allergic conjunctivitis as ophthalmic solution.

As a nasal spray, as a monotherapy or in combination with mometasone furoate, olopatadine is indicated for the symptomatic relief of seasonal allergic rhinitis in patients 12 years of age and older.

Associated Conditions: Allergic Conjunctivitis (AC), Allergic Rhinitis (AR), Seasonal Allergic Rhinitis, Moderate, severe Seasonal Allergic Rhinitis, Ocular effects

Clinical Trials

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Phase 2

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: GSP 301 Placebo NS
Drug: GSP 301-1 NS (QD)
Drug: GSP 301-2 NS (BID)
Drug: Mometasone Furoate-1 NS (QD)
Drug: Mometasone Furoate-2 NS (BID)
Drug: Olopatadine HCl-1 NS (QD)
Drug: Olopatadine HCl-2 NS (BID)

First Posted Date: 2014-12-17

Last Posted Date: 2020-10-20

Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

Target Recruit Count: 1111

Registration Number: NCT02318303

Locations: 🇺🇸
Glenmark Investigational Site 1, Waco, Texas, United States
🇺🇸
Glenmark Investigational Site 7, New Braunfels, Texas, United States
🇺🇸
Glenmark Investigational Site 10, Austin, Texas, United States

and more 7 locations

Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan

Phase 4

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Olopatadine HCl ophthalmic solution, 0.1%
Drug: Epinastine HCl ophthalmic solution, 0.05%

First Posted Date: 2014-09-29

Last Posted Date: 2015-10-07

Lead Sponsor: Alcon Research

Target Recruit Count: 50

Registration Number: NCT02251613

AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Phase 3

Completed

Conditions: Conjunctivitis, Allergic

Interventions: Drug: AGN-229666
Drug: Olopatadine
Drug: Vehicle to AGN-229666

First Posted Date: 2014-06-11

Last Posted Date: 2019-04-17

Lead Sponsor: Allergan

Target Recruit Count: 240

Registration Number: NCT02161146

Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

Phase 3

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Drug: AL-4943A ophthalmic solution
Drug: AL-4943A ophthalmic solution vehicle

First Posted Date: 2012-12-06

Last Posted Date: 2014-08-11

Lead Sponsor: Alcon Research

Target Recruit Count: 902

Registration Number: NCT01743027

A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

Phase 4

Completed

Conditions: Conjunctivitis, Allergic

Interventions: Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Drug: Alcaftadine 0.25%
Drug: Olopatadine 0.2%

First Posted Date: 2012-11-26

Last Posted Date: 2014-01-14

Lead Sponsor: Allergan

Target Recruit Count: 157

Registration Number: NCT01732757

Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Phase 4

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

First Posted Date: 2012-10-02

Last Posted Date: 2014-08-18

Lead Sponsor: Alcon Research

Target Recruit Count: 17

Registration Number: NCT01697969

Locations: 🇺🇸
University of Iowa, Iowa City, Iowa, United States

Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

Phase 3

Withdrawn

Conditions: Allergic Conjunctivitis

Interventions: Drug: Olopatadine Hydrochloride
Drug: PRO-118

First Posted Date: 2012-08-06

Last Posted Date: 2018-10-02

Lead Sponsor: Laboratorios Sophia S.A de C.V.

Registration Number: NCT01657240

A Comparison of the Safety and Comfort of AC-170

Phase 1

Completed

Conditions: Normal Ocular Health

Interventions: Drug: AC-170 0.24% (Formulation 2)
Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II
Drug: AC-170 0.17%
Drug: AC-170 0.24% (Formulation 1)