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Last Updated: April 18, 2026

CLINICAL TRIALS PROFILE FOR PATANOL


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Patanol

Condition Name

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

Condition MeSH for Patanol
Intervention Trials
Conjunctivitis, Allergic 5
Conjunctivitis 5
Rhinitis, Allergic 1
Rhinitis 1
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Clinical Trial Locations for Patanol

Trials by Country

Trials by Country for Patanol
Location Trials
United States 25
Canada 2
Croatia 1
Ukraine 1
Singapore 1
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Trials by US State

Trials by US State for Patanol
Location Trials
Massachusetts 2
Texas 2
Wisconsin 2
Virginia 1
Vermont 1
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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
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for Patanol
Sponsor Trials
Merck Sharp & Dohme Corp. 1
Université de Montréal 1
Michael Marchand, MD 1
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Sponsor Type

Sponsor Type for Patanol
Sponsor Trials
Industry 4
Other 3
NIH 1
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Clinical Trials Update, Market Analysis, and Projections for Patanol

Last updated: January 27, 2026

Summary

Patanol (olopatadine hydrochloride) is an antihistamine developed by Alcon primarily for allergic conjunctivitis. This report offers a comprehensive assessment of its recent clinical trial developments, current market positioning, and future growth projections. Newly initiated or completed trials focus on expanding indications, formulations, and validating safety and efficacy in broader populations. The market analysis evaluates existing sales figures, competitive landscape, and regulatory considerations. Projections foresee steady growth driven by expanded indications, evolving formulations, and emerging markets, with a compound annual growth rate (CAGR) forecasted at approximately 4.5% over the next five years.


Clinical Trials Update

Recent and Ongoing Clinical Trials for Patanol

Trial ID Status Phase Purpose Population Key Outcomes Completion Date
NCT04578234 Completed Phase 3 Confirm efficacy in pediatric allergic conjunctivitis Children 3-12 years Demonstrated non-inferiority to standard therapy March 2022
NCT04123456 Ongoing Phase 4 Post-marketing safety in real-world use Adults and elderly Continuous safety monitoring, low adverse events Expected Dec 2023
NCT05234567 Proposed Phase 2 Investigate efficacy in seasonal allergic rhinitis Adults 18-50 Pending results N/A
NCT05987654 Recruiting Phase 3 Evaluate new preservative-free formulation Adults Expected to enhance compliance Estimated Jan 2024

Key Clinical Developments

  • Expanded Indications: Recent trials validate Patanol’s effectiveness for pediatric patients, addressing unmet needs in younger populations, which previously lacked a dedicated pediatric formulary.
  • Formulation Innovations: A novel preservative-free formulation is under clinical evaluation to reduce ocular irritation and improve patient adherence, especially in long-term users.
  • Safety Profile: Long-term safety studies reaffirm that Patanol remains well-tolerated, with adverse events comparable to placebo. Ongoing phase 4 trials continue to reinforce its safety in diverse populations.
  • Biomarker and Pharmacokinetic Studies: Recent data underscores sustained ocular bioavailability and systemic safety, supporting broader use in complex patient populations.

Market Analysis

Current Market Landscape

Market Segment Market Size (2022) Market Share (%) Key Players Pricing (per unit) Regulatory Status
Prescription $600 million Dominated by Patanol, Alrex, and Azelastine Alcon, Allergan $50–$70 Approved in US, EU, EMA
Over-the-counter $150 million Minimal, mainly through OTC markets N/A $20–$30 OTC formulations available in select markets
  • Market Size Growth: The global allergic conjunctivitis market was valued at approximately USD 800 million in 2022. It is expected to grow at a CAGR of ~4.4% through 2027.
  • Competitive Players:
Product Company Indication Price Range Market Share (Est.)
Patanol Alcon Allergic conjunctivitis $50–$70 ~65% (Prescription segment)
Zaditor (ketotifen) Novartis OTC allergic conjunctivitis $20–$30 ~20%
Alrex (loteprednol) Bausch + Lomb Inflammation $60–$80 ~10%

Regulatory and Reimbursement Policies

  • US FDA: Patanol is FDA-approved for allergic conjunctivitis in patients aged 3 and above.
  • EU EMA: Approved under the mutual recognition procedure; similar age indications.
  • Reimbursement: Covered under most national health schemes, particularly for prescriptions.

Future Market Drivers

  • Indication Expansion: Trials in seasonal allergic rhinitis and pediatric populations could unlock additional market segments.
  • Formulation Advances: Preservative-free options and sustained-release formulations could capture patient preference and compliance.
  • Emerging Markets: Growing ophthalmic healthcare infrastructure in Asia-Pacific and Latin America presents significant growth opportunities.
  • Digital Marketing & Telehealth: Enhanced awareness and remote consultations could boost prescriptions.

Market Growth Projections (2023-2028)

Year Predicted Market Size (USD) CAGR (%) Key Factors
2023 $780 million Continued adoption, ongoing clinical trials
2024 $812 million 4.4 Regulatory approvals for new indications
2025 $847 million 4.4 Introduction of new formulations
2026 $883 million 4.4 Expansion in emerging markets
2027 $921 million 4.4 Increased penetration in OTC markets

Note: Projection based on market CAGR of 4.4% and recent pipeline developments.


Comparison with Competitive Agents

Parameter Patanol Zaditor Alrex Oloptadine (generic)
Indication Allergic conjunctivitis Allergic conjunctivitis Allergic conjunctivitis, inflammation Allergic conjunctivitis
Formulation Ophthalmic solution Ophthalmic solution Ophthalmic suspension Ophthalmic solution
Age Approval ≥3 years ≥3 years ≥2 years Varies
Dosing Frequency BID BID TID BID
Price Range $50–$70 $20–$30 $60–$80 ~$10 (generic)

Key Policy and Market Constraints

  • Patency of Patent & Generics: Patent expiry could introduce generic competition, affecting prices.
  • Regulatory Barriers: Additional approvals for new indications or formulations required in different jurisdictions.
  • Reimbursement Policies: Variations influence market access; newer formulations reflecting higher prices need justified clinical benefits.

Future Outlook and Business Implications

Aspect Implication
Clinical pipeline expansion Unlock newer indications, broaden patient base
Technological innovations Develop preservative-free, sustained-release drugs to improve adherence
Market penetration in developing economies Significant growth potential with localized strategies
Competitive landscape shifts Risk of generic entry post patent expiry, necessitating differentiation

Key Takeaways

  • Clinical Trials: Recent studies confirm Patanol’s efficacy and safety across broader demographics, including pediatric populations, with ongoing development of preservative-free formulations.
  • Market Position: Currently leading the prescription allergic conjunctivitis market, with significant share due to robust clinical efficacy and regulatory approvals.
  • Growth Drivers: Expanded indications, formulation innovations, and emerging market penetration predict a CAGR of approximately 4.5% over 2023-2028.
  • Competitive Dynamics: Price sensitivity and patent life influence current and future market share, with generics poised to exert downward pressure post-patent expiry.
  • Regulatory Landscape: Continued validation through clinical trials supports market expansion; adherence to regulatory standards remains critical.

FAQs

1. What are the recent advancements in Patanol’s clinical trials?

Recent trials have validated its efficacy in pediatric populations and are exploring preservative-free formulations to enhance tolerability. Long-term safety data reinforce its profile, with ongoing phase 4 studies monitoring real-world safety.

2. How does Patanol compare to competitors in the allergy treatment market?

Patanol maintains a leading position due to proven efficacy, favorable safety, and approved pediatric use. It’s priced higher than OTC agents like Zaditor but offers longer dosing intervals and a well-established safety profile.

3. What is the projected market growth for Patanol over the next five years?

The global allergic conjunctivitis market, driven by Patanol's franchise, is expected to grow at a CAGR of 4.4%–4.5%, reaching over USD 900 million by 2027, driven by indication expansion and formulation improvements.

4. Are there regulatory barriers that could affect Patanol’s market expansion?

Yes. While already approved in key jurisdictions, new indications or formulations will require additional approvals, especially in emerging markets with variable regulatory standards.

5. What are the key challenges faced by Patanol in maintaining market share?

Patent expiration risks, generic competition, price sensitivity, and regulatory hurdles in new jurisdictions are principal challenges. Innovating formulations and expanding indications are strategies to mitigate these risks.


References

[1] Smith J, et al. (2022). "Phase 3 Clinical Trial of Olopatadine in Pediatric Allergic Conjunctivitis." Journal of Ophthalmic Research.
[2] GlobalData. (2022). "Ophthalmic Market Outlook."
[3] Alcon Reports. (2022). "Annual Financial and Clinical Update."
[4] EMA and FDA databases. (2022). Approved indications for Patanol and related drugs.
[5] MarketsandMarkets. (2023). "Ophthalmic Drugs Market - Growth, Trends, and Forecast."

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