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Last Updated: January 9, 2025

CLINICAL TRIALS PROFILE FOR OLOPATADINE HYDROCHLORIDE


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All Clinical Trials for OLOPATADINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00331500 ↗ Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis Completed Alcon Research Phase 3 2006-04-18 The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.
NCT00389025 ↗ Mast-Cell Stabilizing Effects of Olopatadine Completed Alcon Research Phase 4 2006-10-01 To assess the effects of olopatadine of the release of mast cell histamine
NCT00489398 ↗ Comparison of CL Wear Between Two Allergy Drops Withdrawn Merck Sharp & Dohme Corp. Phase 4 2007-07-01 Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
NCT00489398 ↗ Comparison of CL Wear Between Two Allergy Drops Withdrawn Hom, Milton M., OD, FAAO Phase 4 2007-07-01 Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
NCT00578331 ↗ Safety Study of Olopatadine Nasal Spray Completed Alcon Research Phase 3 2006-12-01 The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
NCT00578929 ↗ Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Completed Alcon Research Phase 3 2007-09-01 A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OLOPATADINE HYDROCHLORIDE

Condition Name

Condition Name for OLOPATADINE HYDROCHLORIDE
Intervention Trials
Allergic Conjunctivitis 20
Seasonal Allergic Rhinitis 6
Conjunctivitis, Allergic 5
Allergic Rhinitis 4
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Condition MeSH

Condition MeSH for OLOPATADINE HYDROCHLORIDE
Intervention Trials
Conjunctivitis, Allergic 29
Conjunctivitis 28
Rhinitis 15
Rhinitis, Allergic 14
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Clinical Trial Locations for OLOPATADINE HYDROCHLORIDE

Trials by Country

Trials by Country for OLOPATADINE HYDROCHLORIDE
Location Trials
United States 57
Canada 5
Japan 4
India 2
France 1
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Trials by US State

Trials by US State for OLOPATADINE HYDROCHLORIDE
Location Trials
Texas 9
Massachusetts 4
Tennessee 3
Wisconsin 3
Illinois 3
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Clinical Trial Progress for OLOPATADINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for OLOPATADINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 20
Phase 3 13
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for OLOPATADINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 37
Withdrawn 3
Recruiting 2
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Clinical Trial Sponsors for OLOPATADINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for OLOPATADINE HYDROCHLORIDE
Sponsor Trials
Alcon Research 20
Allergan 3
Merck Sharp & Dohme Corp. 2
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Sponsor Type

Sponsor Type for OLOPATADINE HYDROCHLORIDE
Sponsor Trials
Industry 37
Other 9
NIH 1
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OLOPATADINE HYDROCHLORIDE Market Analysis and Financial Projection

Olopatadine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Olopatadine Hydrochloride

Olopatadine hydrochloride is a medication widely used to treat allergic conjunctivitis and other ocular allergies. It is available in various forms, including eye drops and nasal sprays. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Pediatric Patients Study

A clinical trial (EudraCT Number 2017-003841-39) evaluated the safety and efficacy of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients. The trial involved administering 1-2 drops of the solution four times a day (morning, afternoon, evening, and at bedtime) for four weeks. The results indicated no non-serious adverse events, highlighting the safety profile of olopatadine in pediatric patients[1].

Allergic Conjunctivitis and Rhinoconjunctivitis

Another study published in the Investigative Ophthalmology & Visual Science journal assessed the efficacy of 0.2% olopatadine hydrochloride ophthalmic solution in treating ocular itching and redness associated with allergic conjunctivitis or rhinoconjunctivitis. The once-daily administration significantly reduced ocular itching and redness throughout the day, with no identified safety issues[4].

Pharmacokinetics and Safety

Systemic Concentrations

Clinical pharmacokinetic studies have shown that topical ocular administration of olopatadine hydrochloride results in low systemic concentrations. Plasma concentrations were typically below the 0.5 ng/mL quantitation limit, indicating minimal systemic absorption and accumulation with multiple dosing[3].

Metabolites

Olopatadine metabolites in humans were found to be less than 5% of the drug-related material, similar to those observed in animal studies. This suggests a stable and predictable metabolic profile[3].

Market Analysis

Current Market Size and Growth

The olopatadine hydrochloride market has experienced significant growth in recent years. As of 2023, the market size was valued at USD billion and is anticipated to reach USD billion by 2031, reflecting a positive outlook with sustained expansion[2].

Market Segmentation

The market is segmented based on type (99% purity, others), application (nasal spray, eye drops, others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and emerging trends[2].

Drivers and Restraints

Key drivers of the market include increasing prevalence of allergic conditions, growing demand for effective treatments, and advancements in pharmaceutical technology. However, restraints such as regulatory challenges, competition from generic drugs, and economic fluctuations can impact market growth[2].

Market Projections

Forecast Period

The market is forecasted to grow significantly from 2023 to 2031. The comprehensive report by Market Research Intellect provides a detailed analysis of market trends, opportunities, and challenges during this period. The report employs both quantitative and qualitative analyses to project trends and market size in terms of revenue[2].

Regional Insights

The Asia-Pacific region is expected to be a significant contributor to the market growth due to a large patient population and increasing healthcare expenditure. Other regions, such as North America and Europe, will also play crucial roles in the market's expansion[2].

Competitive Landscape

Key Players

The olopatadine hydrochloride market is competitive, with several key players involved in the production and distribution of the drug. These companies focus on product innovation, pricing strategies, and regional market penetration to maintain their market share[5].

Consumer Behavior

Consumer behavior, including preferences for over-the-counter (OTC) versus prescription medications, also influences the market. The convenience and efficacy of olopatadine hydrochloride have made it a preferred choice among patients, contributing to its market growth[2].

Economic, Political, and Social Factors

Economic Landscape

The economic landscape, including healthcare policies and reimbursement scenarios, affects the market. In regions with favorable healthcare policies, the demand for olopatadine hydrochloride is higher due to better access to medications[2].

Political and Social Factors

Political stability and social awareness about health and hygiene also play roles in the market's growth. Public health campaigns and awareness programs can increase the demand for allergy treatments, including olopatadine hydrochloride[2].

Key Takeaways

  • Clinical Trials: Olopatadine hydrochloride has shown efficacy and safety in treating allergic conjunctivitis and other ocular allergies in both pediatric and adult populations.
  • Market Growth: The market is projected to grow significantly from 2023 to 2031, driven by increasing demand and advancements in pharmaceutical technology.
  • Segmentation: The market is segmented by type, application, and geographical regions, which helps in understanding diverse market dynamics.
  • Competitive Landscape: The market is competitive, with key players focusing on product innovation and regional market penetration.
  • Economic and Social Factors: Economic policies, political stability, and social awareness influence the market's growth.

FAQs

What is olopatadine hydrochloride used for?

Olopatadine hydrochloride is used to treat allergic conjunctivitis and other ocular allergies, reducing symptoms such as itching and redness.

What are the common forms of olopatadine hydrochloride?

Olopatadine hydrochloride is available in eye drops and nasal sprays.

What were the findings of the clinical trial in pediatric patients?

The clinical trial found no non-serious adverse events when administering 0.1% olopatadine hydrochloride ophthalmic solution to pediatric patients[1].

How does olopatadine hydrochloride affect systemic concentrations?

Topical ocular administration of olopatadine hydrochloride results in low systemic concentrations, typically below the 0.5 ng/mL quantitation limit[3].

What is the projected market size of olopatadine hydrochloride by 2031?

The market is anticipated to reach USD billion by 2031, reflecting significant growth from 2023[2].

Sources

  1. Clinical Trial Results: Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients. EudraCT Number 2017-003841-39.
  2. Olopatadine Hydrochloride Market Size, Scope And Forecast Report. Market Research Intellect.
  3. Patanol (Olopatadine HCL) 0.1% Topical. FDA.
  4. Effects of Olopatadine Hydrochloride Ophthalmic Solution, 0.2%. Investigative Ophthalmology & Visual Science.
  5. Global Olopatadine Hydrochloride Eye Drops Market Insights. QYResearch.

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