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Last Updated: March 23, 2025

CLINICAL TRIALS PROFILE FOR PATADAY


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All Clinical Trials for Pataday

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00534794 ↗ Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis Completed Merck Sharp & Dohme Corp. Phase 4 2007-10-01 The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
NCT01272089 ↗ A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis Completed Alcon Research Phase 4 2011-05-01 The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.
NCT01450176 ↗ Comparing Patient Satisfaction With Pataday or Bepreve Completed McCabe Vision Center N/A 2011-09-01 The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).
NCT01470118 ↗ A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis Completed Allergan Phase 4 2011-10-01 This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.
NCT01732757 ↗ A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis Completed Allergan Phase 4 2012-11-01 This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.
NCT05265910 ↗ A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis Recruiting Andover Research Eye Institute Phase 4 2021-12-14 This is a single-center, randomized, double-masked, parallel study. In this clinical study, the efficacy comparison between Pataday® Once Daily Relief Extra Strength and Claritin® Tablets 24-Hour will be made using the Ora-CAC model, a validated clinical model accepted by regulatory agents for assessing the efficacy of products on the signs and symptoms of allergic conjunctivitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pataday

Condition Name

Condition Name for Pataday
Intervention Trials
Allergic Conjunctivitis 4
Conjunctivitis, Allergic 2
Eye Allergies 1
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Condition MeSH

Condition MeSH for Pataday
Intervention Trials
Conjunctivitis, Allergic 6
Conjunctivitis 6
Drug Hypersensitivity 1
Hypersensitivity 1
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Clinical Trial Locations for Pataday

Trials by Country

Trials by Country for Pataday
Location Trials
United States 6
India 1
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Trials by US State

Trials by US State for Pataday
Location Trials
Massachusetts 3
Tennessee 2
Pennsylvania 1
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Clinical Trial Progress for Pataday

Clinical Trial Phase

Clinical Trial Phase for Pataday
Clinical Trial Phase Trials
Phase 4 6
N/A 1
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Clinical Trial Status

Clinical Trial Status for Pataday
Clinical Trial Phase Trials
Completed 5
Recruiting 2
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Clinical Trial Sponsors for Pataday

Sponsor Name

Sponsor Name for Pataday
Sponsor Trials
Allergan 2
Andover Research Eye Institute 2
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for Pataday
Sponsor Trials
Industry 6
Other 1
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Pataday: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Pataday, an olopatadine hydrochloride ophthalmic solution, has emerged as a significant player in the treatment of allergic conjunctivitis and related ocular symptoms. This article delves into the clinical trials, market analysis, and future projections for Pataday.

Clinical Trials and Efficacy

Therapeutic Indications

Pataday is indicated for the treatment of ocular itching associated with allergic conjunctivitis and the nasal symptoms of allergic rhinoconjunctivitis. Clinical studies up to 12 weeks have demonstrated its efficacy when dosed once daily[1].

Clinical Study Outcomes

Conjunctival allergen challenge studies have shown that Pataday solution is significantly more effective than its vehicle within 3 minutes after antigen challenge and up to 24 hours after dosing. This rapid and sustained relief underscores its effectiveness in managing ocular allergy symptoms[1].

Safety Profile

The safety profile of Pataday has been evaluated in various studies. While it is generally well-tolerated, adverse reactions such as increased lacrimation, nausea, and hypersensitivity have been reported. However, these reactions are relatively rare and often mild[1].

Market Analysis

Market Size and Growth

The global olopatadine ophthalmic market, which includes Pataday, was estimated to be USD 1636.2 million in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 11% from 2024 to 2031. In North America, the market is expected to grow at a CAGR of 9.2% during the same period[3].

Regional Market Breakdown

  • North America: Expected to reach USD 654.48 million in 2024, with a CAGR of 9.2% from 2024 to 2031.
  • Europe: Projected to reach USD 490.86 million in 2024, with a CAGR of 9.5% from 2024 to 2031.
  • Asia Pacific: Estimated at USD 376.33 million in 2024, with a CAGR of 13.0% from 2024 to 2031[3].

Key Drivers

The market growth is driven by several factors, including an increasing geriatric population, which is more prone to allergic conjunctivitis due to weakened immune systems. Additionally, improved public awareness and direct-to-consumer advertising by pharmaceutical companies have contributed to the growing demand for olopatadine ophthalmic solutions[3].

Over-the-Counter (OTC) Transition

FDA Approval

Pataday Once Daily Relief Extra Strength, containing 0.7% olopatadine hydrochloride, was approved by the FDA for OTC sale in 2021. This transition from a prescription-only to an OTC product has significantly expanded its availability and accessibility to consumers[2].

Market Impact

The OTC transition has been a strategic move by Alcon, marking their third Rx-to-OTC switch in a year. This move is expected to capture a larger market share, especially given that approximately 66 million Americans suffer from ocular allergies, but only 7 million use OTC allergy eye drops[2].

Consumer and Healthcare Professional Perspective

Consumer Benefits

Pataday offers a convenient once-daily dosing regimen, providing full 24-hour relief from eye allergy itch caused by pollen, ragweed, grass, animal hair, and dander. This convenience and efficacy have made it a preferred choice for many consumers[2].

Healthcare Professional Insights

Healthcare professionals view Pataday as an improvement over existing products due to its fast relief and dual mechanism of action as both an antihistamine and a mast cell stabilizer. This has led to its widespread adoption among physicians who previously prescribed Patanol, another olopatadine-based product[5].

Marketing and Sales

Sales Performance

Pataday has a strong sales history, with over 40 million prescriptions written for olopatadine since 2008. The OTC transition has further boosted sales, with 58% of buyers being new to the OTC eye allergy category[2].

Marketing Strategies

Alcon has employed a robust marketing strategy, including TV spots, print ads, and direct-response campaigns. The creative approach, such as the "Art Gallery" TV spot, has helped in positioning Pataday as a premium product in the market[5].

Future Projections

Market Growth

The olopatadine ophthalmic market is expected to continue growing, driven by increasing demand for effective and convenient treatments for allergic conjunctivitis. The global market is projected to expand significantly over the next few years, with regional markets also showing promising growth rates[3].

Competitive Landscape

Pataday will continue to face competition from other ocular allergy treatments, including antihistamines, mast cell stabilizers, decongestants, and NSAIDs. However, its unique once-daily dosing and dual mechanism of action are likely to maintain its competitive edge[5].

Key Takeaways

  • Clinical Efficacy: Pataday has demonstrated significant efficacy in treating ocular itching associated with allergic conjunctivitis and rhinoconjunctivitis.
  • Market Growth: The global olopatadine ophthalmic market is projected to grow at a CAGR of 11% from 2024 to 2031.
  • OTC Transition: The FDA approval for OTC sale has expanded Pataday's availability and accessibility.
  • Consumer and Healthcare Professional Perspective: Pataday is valued for its convenience and efficacy, making it a preferred choice among consumers and healthcare professionals.
  • Future Projections: The market is expected to continue growing, driven by increasing demand for effective treatments for allergic conjunctivitis.

FAQs

What is Pataday used for?

Pataday is used for the treatment of ocular itching associated with allergic conjunctivitis and the nasal symptoms of allergic rhinoconjunctivitis.

How often should Pataday be administered?

Pataday should be administered once daily, with one drop in each affected eye.

Is Pataday available over-the-counter?

Yes, Pataday Once Daily Relief Extra Strength is now available over-the-counter following FDA approval in 2021.

What are the common side effects of Pataday?

Common side effects include increased lacrimation, nausea, and hypersensitivity reactions.

How does Pataday compare to other allergy eye drops?

Pataday offers a unique once-daily dosing regimen and acts as both an antihistamine and a mast cell stabilizer, providing fast and sustained relief.

Sources

  1. Novartis - PATADAY® - Novartis
  2. Ophthalmology Times - Allergy itch relief drop now available over the counter
  3. Cognitive Market Research - Olopatadine Ophthalmic Market Report 2025 (Global Edition)
  4. FDA - CENTER FOR DRUG EVALUATION AND RESEARCH
  5. MM+M - Pataday - MM+M - Medical Marketing and Media

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