CLINICAL TRIALS PROFILE FOR PATANOL

All Clinical Trials for Patanol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00609128 ↗	Effect of Olopatadine on Allergic Tear Mediators	Completed	National Eye Institute (NEI)	N/A	2000-09-01	The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.
NCT00609128 ↗	Effect of Olopatadine on Allergic Tear Mediators	Completed	University of Wisconsin, Madison	N/A	2000-09-01	The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.
NCT01119287 ↗	Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis	Completed	Alcon Research	Phase 4	2010-03-01	The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
NCT01435460 ↗	Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)	Completed	Bausch & Lomb Incorporated	Phase 3	2010-08-01	This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
NCT02478398 ↗	Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2015-07-20	The purpose of this study is to assess the efficacy and safety of short ragweed pollen allergen extract (MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in children aged 5 to 17 years with ragweed-induced allergic rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is that administration of short ragweed pollen allergen extract sublingual immunotherapy tablets to children 5 to 17 years of age, compared with placebo, will result in a significant reduction in the combination of rhinoconjunctivitis symptoms and medication use over the peak ragweed season (RS).
NCT03186755 ↗	Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis	Recruiting	Université de Montréal	Phase 4	2017-06-11	This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% & Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.
NCT03186755 ↗	Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis	Recruiting	Michael Marchand, MD	Phase 4	2017-06-11	This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% & Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.

Clinical Trial Conditions for Patanol

Condition Name

Condition Name for Patanol
Intervention	Trials
Allergic Conjunctivitis	3
Allergic Eye Disease	1
Conjunctivitis, Allergic	1
Conjunctivitis, Vernal	1

Condition MeSH

Condition MeSH for Patanol
Intervention	Trials
Conjunctivitis, Allergic	5
Conjunctivitis	5
Rhinitis	1
Eye Diseases	1

Clinical Trial Locations for Patanol

Trials by Country

Trials by Country for Patanol
Location	Trials
United States	25
Canada	2
Singapore	1
Serbia	1
Hungary	1

Trials by US State

Trials by US State for Patanol
Location	Trials
Massachusetts	2
Texas	2
Wisconsin	2
Pennsylvania	1
Ohio	1

Clinical Trial Progress for Patanol

Clinical Trial Phase

Clinical Trial Phase for Patanol
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Patanol
Clinical Trial Phase	Trials
Completed	5
Recruiting	1

Clinical Trial Sponsors for Patanol

Sponsor Name

Sponsor Name for Patanol
Sponsor	Trials
Université de Montréal	1
Michael Marchand, MD	1
ORA, Inc.	1

Sponsor Type

Sponsor Type for Patanol
Sponsor	Trials
Industry	4
Other	3
NIH	1

Patanol (Olopatadine Hydrochloride Ophthalmic Solution): Clinical Trials, Market Analysis, and Projections

Introduction

Patanol, also known as olopatadine hydrochloride ophthalmic solution, is a widely used medication for the treatment of allergic conjunctivitis. This article will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Study Design and Efficacy

Clinical trials for Patanol, particularly those for the 0.1%, 0.2%, and 0.7% concentrations, have been extensive. Studies C-10-126 and C-12-053 were multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies. These studies utilized the Conjunctival Allergen Challenge (CAC) model, a standard design for evaluating ocular itching treatments. Patients were challenged with progressively higher doses of antigen to induce a ≥2+ itching and redness reaction, and the efficacy of olopatadine was assessed at various time points after antigen administration[1].

Safety Studies

A six-week safety study (C-12-028) provided crucial safety data for subjects who may use the product. This study was also multicenter, randomized, and double-masked, ensuring robust safety information[1].

Pediatric Studies

A clinical trial (EudraCT number 2017-003841-39) evaluated the use of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients. This one-arm descriptive study provided descriptive statistics on efficacy and safety, although no hypothesis testing was performed[4].

Market Analysis

Current Market Size and Growth

The ophthalmic drugs market, which includes Patanol, is significant and growing. As of 2015, the market was forecasted to see substantial growth, with revenues predicted to rise significantly by 2025. Patanol, along with other brands like Lucentis and Eylea, was highlighted as a key player in this market[2].

Regional Market Prospects

The market for ophthalmic drugs, including Patanol, varies by region. The US, China, Japan, and India are among the leading national markets. Emerging economies, particularly in South America and Asia, are expected to drive high revenue growth due to expanding healthcare coverage and increasing demand for ophthalmic treatments[2].

Competitive Landscape

Patanol competes in a market dominated by several major pharmaceutical companies, including Pfizer, Novartis (Alcon), Allergan (Actavis), and Bayer. These companies are actively involved in research and development, mergers and acquisitions, and strategic partnerships, which influence the market dynamics[2].

Market Projections

Revenue Forecasts

The ophthalmic drugs market, including the segment for allergic, inflammatory, and infective drugs where Patanol is categorized, is projected to continue growing. By 2025, the market was expected to show significant revenue increases, and this trend is anticipated to continue up to 2034. The allergic conjunctivitis segment, which Patanol addresses, is expected to retain its dominance due to a strong product pipeline and high R&D expenditure[5].

Segment Growth

The allergic conjunctivitis segment, where Patanol is a key player, contributed the largest market share in recent years. This is due to the high prevalence of allergic conjunctivitis and the effectiveness of treatments like Patanol. The market is expected to grow at a CAGR of around 5% from 2025 to 2034, driven by factors such as increasing exposure to allergens and advancements in treatment options[5].

Key Players and Innovations

Leading Companies

Companies like Novartis (Alcon), Allergan (Actavis), and Bayer are significant players in the ophthalmic drugs market. These companies are continuously innovating and expanding their product portfolios, which includes drugs like Patanol. Their activities in mergers and acquisitions, collaborations, and research and development are crucial for market growth[2].

Emerging Trends

The ophthalmic drugs market is also seeing emerging trends in drug delivery technologies and the development of new treatments. For example, Aldeyra Therapeutics is working on new treatments for dry eye disease, which could potentially impact the broader ophthalmic market and influence the competitive landscape for drugs like Patanol[3].

Regulatory and Economic Factors

Regulatory Changes

Regulatory changes and approvals play a critical role in the ophthalmic drugs market. For instance, the FDA's approval process and guidelines can significantly impact the launch and success of new drugs. Companies must navigate these regulatory environments to ensure their products meet safety and efficacy standards[2].

Economic Factors

Economic factors such as healthcare coverage expansion and increasing healthcare expenditure in both developed and developing countries are driving the growth of the ophthalmic drugs market. Emerging economies, in particular, offer significant opportunities for market growth due to their large populations and increasing demand for healthcare services[2].

Key Takeaways

• Clinical Trials: Patanol has undergone extensive clinical trials using the CAC model, demonstrating its efficacy and safety in treating allergic conjunctivitis.
• Market Size and Growth: The ophthalmic drugs market, including Patanol, is projected to grow significantly, driven by increasing demand and advancements in treatment options.
• Regional Prospects: Emerging economies in South America and Asia are expected to drive high revenue growth in the ophthalmic drugs market.
• Competitive Landscape: Major pharmaceutical companies are actively involved in R&D, mergers and acquisitions, and strategic partnerships, influencing market dynamics.
• Regulatory and Economic Factors: Regulatory approvals and economic factors such as healthcare coverage expansion are crucial for market growth.

FAQs

What is Patanol used for?

Patanol (olopatadine hydrochloride ophthalmic solution) is used for the treatment of allergic conjunctivitis, specifically to alleviate ocular itching and redness associated with allergies.

What are the key clinical trials for Patanol?

The key clinical trials for Patanol include studies C-10-126 and C-12-053, which used the Conjunctival Allergen Challenge (CAC) model to evaluate the efficacy and safety of olopatadine.

How is the market for ophthalmic drugs projected to grow?

The ophthalmic drugs market, including the segment for allergic conjunctivitis, is projected to grow at a CAGR of around 5% from 2025 to 2034, driven by increasing demand and advancements in treatment options.

Which regions are expected to drive market growth for ophthalmic drugs?

Emerging economies in South America and Asia, along with developed markets like the US, China, and Japan, are expected to drive significant growth in the ophthalmic drugs market.

What are the major companies involved in the ophthalmic drugs market?

Major companies such as Novartis (Alcon), Allergan (Actavis), Bayer, and Pfizer are key players in the ophthalmic drugs market, actively involved in R&D, mergers and acquisitions, and strategic partnerships.

How do regulatory changes impact the ophthalmic drugs market?

Regulatory changes and approvals significantly impact the launch and success of new drugs in the ophthalmic market. Companies must comply with FDA guidelines and other regulatory standards to ensure their products meet safety and efficacy criteria.

Sources

1. FDA: 206276 Olopatadine Clinical 2 BPCA - FDA
2. PR Newswire: Ophthalmic Drugs Market Forecast 2015-2025: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs
3. Aldeyra Therapeutics: Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
4. EudraCT: Clinical Trial Results: Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
5. Precedence Research: Conjunctivitis Market Size to Hit USD 8.66 Billion by 2034