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

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis

Phase 4

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: olopatadine hydrochloride ophthalmic solution 0.7%)
Drug: Fluticasone Propionate
Drug: Saline nasal spray
Drug: Tears Naturale

First Posted Date: 2022-04-06

Last Posted Date: 2022-09-02

Lead Sponsor: Andover Research Eye Institute

Target Recruit Count: 61

Registration Number: NCT05314621

Locations: 🇺🇸
Andover Eye Associates, Andover, Massachusetts, United States

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis

Phase 4

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: olopatadine hydrochloride ophthalmic solution 0.7%
Drug: loratadine 10 mg
Drug: Placebo
Drug: Tears Naturale

First Posted Date: 2022-03-04

Last Posted Date: 2022-05-03

Lead Sponsor: Andover Research Eye Institute

Target Recruit Count: 58

Registration Number: NCT05265910

Locations: 🇺🇸
Andover Eye Associates, Andover, Massachusetts, United States

Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment

Phase 4

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Bepotastine Besilate 1.5% PF
Drug: Olopatadine Hydrochloride 0.2% BAK

First Posted Date: 2021-03-01

Last Posted Date: 2022-12-15

Lead Sponsor: Laboratorios Poen

Target Recruit Count: 97

Registration Number: NCT04776096

Locations: 🇦🇷
Hospital Santa Lucía, Caba, Argentina
🇦🇷
Hospital de Alta Complejidad El Cruce - Nestor Kirchner, Caba, Argentina
🇦🇷
Instituto Oftalmológico Pedro Lagleyze, Caba, Argentina

and more 1 locations

DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Phase 4

Completed

Conditions: Bilateral Conjunctivitis (Disorder)

Interventions: Drug: Dexamethasone ophthalmic insert 0.4Mg
Drug: 0.2% loteprednol etabonate ophthalmic suspension
Drug: olopatadine hydrochloride ophthalmic solution 0.7%

First Posted Date: 2021-01-14

Last Posted Date: 2022-04-13

Lead Sponsor: Clinical Research Center of Florida

Target Recruit Count: 31

Registration Number: NCT04708821

Locations: 🇺🇸
Clinical Research Center of Florida, Pompano Beach, Florida, United States

Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 2

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Placebo nasal spray
Drug: Molo 1 (also referred as GSP 301-2 NS)
Drug: Molo 2 (also referred as GSP 301-1 NS)
Drug: DYMISTA nasal spray
Drug: PATANASE nasal spray

First Posted Date: 2018-02-23

Last Posted Date: 2018-06-20

Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

Target Recruit Count: 180

Registration Number: NCT03444506

Locations: 🇨🇦
Glenmark Investigational Site 1, Mississauga, Ontario, Canada

Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

Phase 2

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Patanol
Drug: PRT-2761 1%
Drug: Pred-forte
Drug: PRT-2761 0.5%
Drug: PRT-2761 0%

First Posted Date: 2017-10-25

Last Posted Date: 2022-10-17

Lead Sponsor: ORA, Inc.

Target Recruit Count: 120

Registration Number: NCT03320434

Locations: 🇺🇸
Andover Eye Associates, Andover, Massachusetts, United States

Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis

Phase 4

Recruiting

Conditions: Conjunctivitis, Allergic
Conjunctivitis, Vernal

Interventions: Drug: Hyaluronic acid 0.05% & Ectoine 2.0%
Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

First Posted Date: 2017-06-14

Last Posted Date: 2022-10-26

Lead Sponsor: Michael Marchand, MD

Target Recruit Count: 42

Registration Number: NCT03186755

Locations: 🇨🇦
CHU Sainte-Justine Hospital, Montréal, Quebec, Canada

Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: GSP 301 Placebo NS
Drug: Olopatadine HCl NS
Drug: GSP 301 NS
Drug: Mometasone furoate NS

First Posted Date: 2015-12-16

Last Posted Date: 2018-09-25

Lead Sponsor: Glenmark Specialty S.A.

Target Recruit Count: 1180

Registration Number: NCT02631551

Locations: 🇺🇸
Investigational Site 20, Mission Viejo, California, United States
🇺🇸
Investigational Site 25, Centennial, Colorado, United States
🇺🇸
Investigational Site 31, San Diego, California, United States

and more 34 locations