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Last Updated: April 20, 2025

CLINICAL TRIALS PROFILE FOR CYCLOPENTOLATE HYDROCHLORIDE


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All Clinical Trials for Cyclopentolate Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00348166 ↗ Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten Children? Withdrawn KK Women's and Children's Hospital Phase 1 2005-12-01 The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.
NCT01170130 ↗ Lidocaine Usage for Pupil Dilatation (Mydriasis) Completed Carmel Medical Center N/A 2009-12-01 The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.
NCT02177539 ↗ A New More Efficient Cycloplegia Scheme Unknown status Pontificia Universidad Catolica de Chile Phase 4 2014-05-01 The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)
NCT02309385 ↗ Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis Completed National Eye Institute (NEI) Phase 1/Phase 2 2014-10-01 The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.
NCT02309385 ↗ Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis Completed Aciont Inc Phase 1/Phase 2 2014-10-01 The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyclopentolate Hydrochloride

Condition Name

Condition Name for Cyclopentolate Hydrochloride
Intervention Trials
Cataract 3
Refractive Errors 2
Cycloplegia 2
Retinopathy of Prematurity 1
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Condition MeSH

Condition MeSH for Cyclopentolate Hydrochloride
Intervention Trials
Mydriasis 3
Cataract 3
Refractive Errors 3
Myopia 3
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Clinical Trial Locations for Cyclopentolate Hydrochloride

Trials by Country

Trials by Country for Cyclopentolate Hydrochloride
Location Trials
United States 5
Jordan 2
Oman 1
Egypt 1
Chile 1
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Trials by US State

Trials by US State for Cyclopentolate Hydrochloride
Location Trials
Utah 1
Texas 1
North Dakota 1
North Carolina 1
Massachusetts 1
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Clinical Trial Progress for Cyclopentolate Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cyclopentolate Hydrochloride
Clinical Trial Phase Trials
Phase 4 6
Phase 3 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Cyclopentolate Hydrochloride
Clinical Trial Phase Trials
Completed 5
Unknown status 2
Enrolling by invitation 1
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Clinical Trial Sponsors for Cyclopentolate Hydrochloride

Sponsor Name

Sponsor Name for Cyclopentolate Hydrochloride
Sponsor Trials
Islamic Hospital, Jordan 2
Aciont Inc 1
Milton S. Hershey Medical Center 1
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Sponsor Type

Sponsor Type for Cyclopentolate Hydrochloride
Sponsor Trials
Other 15
NIH 1
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Cyclopentolate Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Cyclopentolate Hydrochloride

Cyclopentolate hydrochloride is a muscarinic antagonist commonly used in ophthalmology as an eye drop to dilate pupils (mydriatic) and prevent the eye from focusing or accommodating (cycloplegic). It is particularly useful during pediatric eye examinations and in various ophthalmic procedures.

Clinical Use and Applications

Mydriatic and Cycloplegic Agent

Cyclopentolate hydrochloride is primarily used to dilate pupils and temporarily paralyze the ciliary muscles, facilitating thorough retina and corneal assessments. This is crucial for diagnosing and treating various eye conditions, especially in children where cooperation may be limited[2].

Muscarinic Receptor Antagonist

In addition to its ophthalmic use, cyclopentolate can be used to reverse the muscarinic and central nervous system effects of indirect cholinomimetic agents. This makes it a versatile drug in both ophthalmology and emergency medicine[2].

Market Analysis

Current Market Size and Growth

The global cyclopentolate hydrochloride market has been experiencing significant growth. As of 2023, the market was valued at approximately $1.142 billion and is projected to reach $1.551 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2030[2].

Market Segmentation

The market is segmented based on type (patent and generic) and application (mydriatic agent and muscarinic receptor antagonist). The generic segment is expected to grow significantly due to its cost-effectiveness and widespread acceptance[2].

Regional Market Analysis

  • North America: This region leads the market due to its advanced healthcare infrastructure, substantial R&D investments, and a favorable regulatory environment.
  • Europe: A mature market with well-established infrastructure, Europe is another major region.
  • Asia-Pacific: This region is experiencing rapid growth driven by countries like China, Japan, India, and South Korea, due to a large population, rising disposable income, and increasing urbanization[2][4].

Drivers of Market Growth

Increasing Prevalence of Eye Conditions

The rising incidence of eye disorders, particularly among the geriatric population, is driving the demand for cyclopentolate hydrochloride eye drops. Routine eye screenings and advancements in ophthalmic treatments also contribute to this growth[4].

Urbanization and Growing Healthcare Expenditure

Urbanization, especially in developing countries, has led to an increased demand for specific ophthalmic solutions, including cyclopentolate hydrochloride eye drops. Growing healthcare expenditure and improving regulatory frameworks in these regions further support market growth[4].

Technological Advancements

While not directly related to cyclopentolate hydrochloride, advancements in ophthalmic treatments and diagnostic practices enhance the overall demand for eye care products, including these eye drops[4].

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand product portfolios, and leverage synergies to drive growth and competitiveness[4].

Challenges and Restraints

Regulatory Environment

Stringent regulatory requirements can pose challenges for new entrants and existing players in the market. Compliance with these regulations is crucial for market success[2].

Economic Fluctuations

Economic instability in certain regions, such as Latin America, can impact market dynamics and consumer behavior, affecting the overall growth of the cyclopentolate hydrochloride market[4].

Competitive Landscape

Key Players

The market is dominated by several key players, including Alcon, Novartis, Bausch and Lomb, Akorn Pharma, and others. These companies are engaged in strategic consolidations and innovations to maintain their market positions[2][4].

Market Concentration Rate

The market concentration rate indicates a moderate level of competition, with a few major players holding significant market shares. However, the presence of generic options keeps the market competitive[2].

Future Outlook and Projections

Market Size Projections

The cyclopentolate hydrochloride eye drops market is expected to grow significantly, reaching a valuation of $18.13 billion by 2031 from $8.1 billion in 2024. This growth is driven by increasing demand for ophthalmic solutions and expanding diagnostic practices[4].

Emerging Trends

  • Sustainable Solutions: There is a growing demand for eco-friendly and sustainable ophthalmic products, which could influence the development of new formulations.
  • Technological Innovations: Advances in ophthalmic treatments and diagnostic technologies will continue to drive the market forward.
  • Expanding into New Markets: The Asia-Pacific region, particularly countries like China and India, presents significant growth opportunities due to their large populations and improving healthcare infrastructure[4].

Key Takeaways

  • The cyclopentolate hydrochloride market is experiencing robust growth driven by increasing eye condition prevalence, urbanization, and advancements in ophthalmic treatments.
  • The market is segmented by type and application, with the generic segment expected to grow significantly.
  • North America and Europe are major regions, while the Asia-Pacific region is the fastest-growing market.
  • Key players are engaging in mergers and acquisitions to consolidate their market positions.
  • The market is projected to reach $18.13 billion by 2031.

FAQs

What is the current market size of the cyclopentolate hydrochloride market?

The global cyclopentolate hydrochloride market was valued at approximately $1.142 billion in 2023[2].

What is the projected growth rate of the cyclopentolate hydrochloride market?

The market is expected to grow at a CAGR of 4.5% from 2024 to 2030[2].

Which regions are the major markets for cyclopentolate hydrochloride?

North America, Europe, and the Asia-Pacific region are the major markets, with the Asia-Pacific region being the fastest-growing[2][4].

What are the primary applications of cyclopentolate hydrochloride?

The primary applications are as a mydriatic agent and a muscarinic receptor antagonist[2].

What are the key drivers of the cyclopentolate hydrochloride market growth?

Key drivers include the increasing prevalence of eye conditions, urbanization, growing healthcare expenditure, and technological advancements in ophthalmic treatments[4].

Sources

  1. Market Research Intellect: Global Cyclopentolate Hydrochloride Eye Drops Market Size, Scope ...
  2. QYResearch: Global Cyclopentolate Market Research Report 2024
  3. OpenPR: Cyclopentolate Hydrochloride Eye Drops Market Size, Share and Forecast By Key Players
  4. Volza: Cyclopentolate Hydrochloride Imports in World - Volza

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