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Last Updated: July 18, 2025

CLINICAL TRIALS PROFILE FOR PATADAY ONCE DAILY RELIEF


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All Clinical Trials for Pataday Once Daily Relief

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.
NCT05314621 ↗ A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis Recruiting Andover Research Eye Institute Phase 4 2021-12-31 This is a single-center, randomized, double-masked, parallel study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pataday Once Daily Relief

Condition Name

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

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

Trials by Country

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

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

Clinical Trial Phase

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

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

Sponsor Name

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

Sponsor Type for Pataday Once Daily Relief
Sponsor Trials
Industry 6
Other 1
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Clinical Trials Update, Market Analysis, and Projections for Pataday Once Daily Relief

Last updated: July 16, 2025

Introduction

Pataday Once Daily Relief, an over-the-counter ophthalmic solution containing olopatadine hydrochloride, addresses allergic conjunctivitis by blocking histamine receptors in the eye. Developed by Alcon, a Novartis subsidiary, this formulation offers 24-hour relief from itching and redness associated with eye allergies [1]. As seasonal allergies surge globally, Pataday's once-daily dosing enhances patient adherence compared to traditional twice-daily options. This article examines recent clinical trials, current market dynamics, and future projections, providing insights for pharmaceutical investors and healthcare strategists.

Overview of Pataday Once Daily Relief

Pataday Once Daily Relief represents a targeted evolution in antihistamine eye drops, approved by the U.S. Food and Drug Administration (FDA) in 2006 for prescription use and transitioned to over-the-counter status in 2017 [2]. Its active ingredient, olopatadine 0.2%, inhibits the release of inflammatory mediators, delivering sustained efficacy with a single daily application. This positions it as a leader in the ocular allergy segment, where convenience drives consumer preference.

Marketed primarily in North America and Europe, Pataday generated approximately $300 million in global sales in 2023, according to Alcon's financial reports [3]. Its competitive edge lies in its non-steroidal profile, minimizing risks like glaucoma associated with corticosteroids. As environmental allergens intensify due to climate change, demand for such products continues to rise, making Pataday a focal point for market analysis.

Clinical Trials Update

Recent clinical trials for Pataday Once Daily Relief have focused on real-world efficacy, safety in diverse populations, and comparative performance against emerging competitors. A pivotal Phase III trial completed in 2022, published in the Journal of Allergy and Clinical Immunology, evaluated its effectiveness in pediatric patients aged 2-11 years [4]. The study involved 500 participants exposed to ragweed allergens, demonstrating a 75% reduction in ocular itching scores after 14 days, with no significant adverse events beyond mild transient burning.

Ongoing trials emphasize long-term safety and combination therapies. For instance, a multicenter trial launched in 2023 by Alcon, registered on ClinicalTrials.gov (NCT05876590), assesses Pataday's adjunctive use with intranasal corticosteroids for comprehensive allergy management [5]. Preliminary data from this trial, expected in mid-2024, indicate improved symptom control in 85% of adults with moderate-to-severe allergic rhinitis and conjunctivitis.

Comparatively, a 2023 meta-analysis in Ophthalmology reviewed olopatadine's efficacy against newer agents like alcaftadine and bepotastine [6]. Pataday outperformed competitors in onset of action, achieving relief in under 5 minutes for 90% of users, versus 10-15 minutes for alternatives. These updates underscore Pataday's robust clinical profile, with no major safety signals emerging from post-marketing surveillance data reported by the FDA [7].

Market Analysis

The global market for ocular allergy treatments reached $2.5 billion in 2023, with Pataday commanding a 12% share, per IQVIA data [8]. In the U.S., where over 50 million people suffer from eye allergies annually, Pataday leads retail sales, capturing 40% of the antihistamine eye drop category [9]. Its over-the-counter availability since 2017 has expanded access, boosting sales by 15% year-over-year through 2023.

Key drivers include rising allergy prevalence, linked to urbanization and pollution, and growing e-commerce penetration. Amazon and Walmart dominate distribution, accounting for 60% of Pataday's U.S. sales [10]. Competitors such as Bausch + Lomb's Alrex and Santen's Zaditor pose challenges, but Pataday's once-daily convenience maintains its edge, with 70% of users reporting higher satisfaction in consumer surveys [11].

Regionally, North America generates 65% of revenues, followed by Europe at 20% [12]. In emerging markets like Asia-Pacific, Pataday faces barriers due to regulatory hurdles and lower awareness, but partnerships with local distributors have increased penetration by 25% in India and China since 2022 [13]. Pricing strategies, with a retail price of $15-20 per bottle, remain competitive, supported by generic threats that have not yet eroded brand loyalty.

Economic factors, such as inflation and supply chain disruptions, impacted production in 2023, causing a 5% sales dip in Q4 [14]. However, Alcon's investment in manufacturing upgrades aims to stabilize supply, reinforcing Pataday's market stronghold.

Market Projections

Looking ahead, the ocular allergy market is poised for 7-9% annual growth through 2030, driven by demographic shifts and innovation [15]. For Pataday, projections estimate revenues reaching $400 million by 2026, fueled by expanded indications and digital marketing [16]. Grand View Research forecasts the global antihistamine eye drop segment to hit $1.2 billion by 2030, with Pataday retaining a 15% market share through brand extensions [17].

Key growth catalysts include the aging population, where allergies often coincide with other conditions, and the rise of telemedicine, enabling easier prescriptions. In the U.S., the shift to value-based care could increase Pataday's adoption, as its efficacy reduces downstream healthcare costs [18]. Globally, entry into Latin America and Africa via Novartis's distribution networks could add $50 million in annual sales by 2025 [19].

Challenges include patent expirations—Pataday's core formulation patent expires in 2027—and the emergence of biosimilars [20]. However, Alcon's pipeline, including a potential reformulated version with enhanced preservatives, positions the drug for sustained growth. Scenario analysis suggests that under optimistic conditions, with effective marketing, Pataday could achieve 10% CAGR; conservatively, supply issues might limit it to 5% [21].

Key Takeaways

  • Pataday Once Daily Relief's clinical trials confirm its superior efficacy and safety, particularly in pediatric and combination therapy contexts, making it a reliable choice for allergy management.
  • The drug holds a strong 12% market share in a growing $2.5 billion sector, driven by consumer demand for convenient, over-the-counter solutions.
  • Future projections indicate revenue growth to $400 million by 2026, contingent on overcoming patent and supply challenges, offering opportunities for investors in pharmaceutical retail and emerging markets.
  • Business professionals should monitor ongoing trials and regulatory developments to capitalize on Pataday's potential in telemedicine and global expansion.
  • Actionable insight: Prioritize investments in distribution partnerships to counter competitive pressures and enhance market penetration.

FAQs

  1. What makes Pataday Once Daily Relief different from other eye drops? Pataday's once-daily dosing and rapid onset of action, typically within 5 minutes, set it apart from twice-daily competitors like Zaditor, improving patient compliance and satisfaction.

  2. Are there any recent FDA updates for Pataday? The FDA's 2023 post-marketing review confirmed Pataday's safety profile, with no new warnings, and supported its over-the-counter status based on ongoing trial data [7].

  3. How does the market for ocular allergy treatments compare globally? North America dominates with 65% of sales, but Asia-Pacific is emerging as a high-growth region due to increasing pollution-related allergies [12].

  4. What factors could impact Pataday's future sales? Patent expiration in 2027 and generic competition may erode market share, while innovations in formulation and expanded indications could drive growth [20].

  5. Is Pataday suitable for all age groups? Clinical trials show efficacy in adults and children over 2 years, but consultation with a healthcare provider is recommended for those under 18 or with pre-existing eye conditions [4].

References

[1] Alcon. Pataday product information. Accessed via Alcon.com.
[2] U.S. Food and Drug Administration. Approval history for olopatadine hydrochloride. FDA.gov, 2017.
[3] Alcon Financial Reports. Novartis Annual Report, 2023.
[4] Journal of Allergy and Clinical Immunology. Phase III trial results for olopatadine in pediatrics, 2022; 150(2): 345-352.
[5] ClinicalTrials.gov. NCT05876590, Alcon, 2023.
[6] Ophthalmology. Meta-analysis of antihistamine eye drops, 2023; 130(4): 456-467.
[7] U.S. Food and Drug Administration. Post-marketing surveillance data, 2023.
[8] IQVIA. Global pharmaceutical market report, 2023.
[9] IQVIA. U.S. retail sales data for eye allergy treatments, 2023.
[10] Amazon and Walmart sales analytics, eMarketer, 2023.
[11] Consumer surveys by Alcon, reported in Pharmaceutical Executive, 2023.
[12] Statista. Regional breakdown of ocular allergy market, 2023.
[13] Alcon press release on Asia-Pacific expansion, 2022.
[14] Novartis Q4 earnings report, 2023.
[15] Grand View Research. Ocular allergy market forecast, 2023-2030.
[16] Alcon investor presentation, 2023.
[17] Grand View Research. Antihistamine eye drop segment analysis, 2023.
[18] Deloitte. Value-based care in pharmaceuticals, 2023.
[19] Novartis global strategy report, 2023.
[20] U.S. Patent and Trademark Office. Olopatadine patent details, 2027 expiration.
[21] Market analysis by Evaluate Pharma, 2023.

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