CLINICAL TRIALS PROFILE FOR CYCLOPENTOLATE HYDROCHLORIDE

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	Withdrawn	KK Women's and Children's Hospital	Phase 1	2005-12-01	The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia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.
NCT02895035 ↗	Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size	Terminated	Milton S. Hershey Medical Center	Phase 4	2016-09-01	The objective of this study is to compare the maintenance of intraoperative mydriasis during cataract surgery between two drugs: epinephrine, which has routinely been used for decades, and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients undergoing cataract surgery that are enrolled in the trial will randomly receive one of the drugs in one eye, and the other eye will receive the drug during the subsequent cataract surgery.
NCT03508817 ↗	Atropine 0.01% Eye Drops in Myopia Study	Enrolling by invitation	Christian Medical College, Vellore, India	Early Phase 1	2018-12-20	Control of myopia progression has become an important goal because of concerns regarding significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. It is also clear there prevalence of myopia in children and young adults is increasing all over the world. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity. Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy (concentration and dosing) and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical 0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups. Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase 1). Control group will not receive any medications. Follow up visits will be scheduled every three months in Phase 1. Subsequently, medication will be stopped and the study patients will be followed up every six months for one year (Phase 2). The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods.

Clinical Trial Conditions for CYCLOPENTOLATE HYDROCHLORIDE

Condition Name

Condition Name for CYCLOPENTOLATE HYDROCHLORIDE
Intervention	Trials
Cataract	3
Myopia	3
Refractive Errors	2
Cycloplegia	2

Condition MeSH

Condition MeSH for CYCLOPENTOLATE HYDROCHLORIDE
Intervention	Trials
Myopia	5
Cataract	3
Refractive Errors	3
Mydriasis	3

Clinical Trial Locations for CYCLOPENTOLATE HYDROCHLORIDE

Trials by Country

Trials by Country for CYCLOPENTOLATE HYDROCHLORIDE
Location	Trials
United States	5
Jordan	2
Egypt	1
Albania	1
Spain	1

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

Clinical Trial Progress for CYCLOPENTOLATE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CYCLOPENTOLATE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for CYCLOPENTOLATE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	5
NOT_YET_RECRUITING	3
Unknown status	2

Clinical Trial Sponsors for CYCLOPENTOLATE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CYCLOPENTOLATE HYDROCHLORIDE
Sponsor	Trials
Islamic Hospital, Jordan	2
Mansoura University	2
Euromed Pharma Services SRL	1

Sponsor Type

Sponsor Type for CYCLOPENTOLATE HYDROCHLORIDE
Sponsor	Trials
Other	18
INDUSTRY	2
NIH	1

Clinical Trials, Market Analysis, and Projections for Cyclopentolate Hydrochloride

Last updated: October 31, 2025

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Introduction

Cyclopentolate hydrochloride is a potent mydriatic and cycloplegic agent widely used in ophthalmic diagnostics and procedures. The drug’s ability to induce pupil dilation facilitates accurate eye examinations, especially in pediatric and adult patients. Given its extensive clinical utility, recent developments in clinical trials, market dynamics, and future projections are critical for stakeholders including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

Ongoing Research and Emerging Indications

Recent clinical trials have expanded the scope of cyclopentolate hydrochloride beyond its traditional use for pupillary dilation. Notably, trials investigating its efficacy in managing conditions such as accommodative spasms, myopia control, and combination therapies in anterior segment surgeries are underway.

For instance, a 2022 randomized controlled trial (RCT) published in the Journal of Ophthalmology explored the safety and efficacy of varying concentrations of cyclopentolate in pediatric populations. The study concluded that 0.5% to 1% formulations maintain a favorable safety profile while providing effective dilation, aligning with existing safety data [1].

Safety and Tolerability Data

The FDA and EMA continue to scrutinize the safety profile of cyclopentolate hydrochloride, particularly concerning adverse reactions like systemic toxicity in pediatric patients. Current literature emphasizes minimal systemic effects when used within recommended doses. Trials assessing alternative delivery mechanisms, such as sustained-release formulations, aim to enhance patient compliance and safety.

Innovations in Formulation

Pharmaceutical companies are investing in novel delivery systems, including micellar solutions and combination eye drops, to optimize drug absorption and reduce side effects. For example, a 2023 phase I trial evaluated a liposome-encapsulated cyclopentolate formulation, reporting promising pharmacokinetics and reduced systemic absorption [2].

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Market Analysis

Current Market Landscape

The global ophthalmic diagnostics market continues to expand, driven by increasing prevalence of ocular diseases, advancements in diagnostic technologies, and an aging population. Cyclopentolate hydrochloride, as a staple in ophthalmic examinations, holds significant market share within ophthalmic pharmacology.

According to a 2022 report from Grand View Research, the global ophthalmic drugs market was valued at USD 33.2 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% from 2022 to 2030 [3]. Cyclopentolate remains a crucial component, with sales expected to follow the market trajectory, especially in emerging economies where ophthalmic healthcare infrastructure evolves.

Market Segmentation and Regional Insights

The pharmaceutical market for cyclopentolate is segmented based on formulation, distribution channel, and end-user:

• Formulation: Single-dose eye drops dominate, accounting for over 70% of sales.
• Distribution Channels: Hospital pharmacies and online pharmacies are key sales channels, reflecting increased outpatient procedures.
• Regions: North America holds the largest market share due to high healthcare expenditure, widespread clinical protocols, and robust research activities. The Asia-Pacific region is anticipated to experience the fastest growth (CAGR ~6.2%), driven by population growth, increased ophthalmic disease prevalence, and expanding healthcare infrastructure [3].

Competitive Landscape

Major pharmaceutical players include Alcon, Bausch + Lomb, and Sandoz, each offering proprietary formulations. Generic versions also contribute significantly to market competitiveness, with several regional manufacturers gaining share through cost-effective solutions.

Patent expirations for certain formulations have catalyzed market entry of generics, intensifying competitive dynamics. Furthermore, collaborations with contract manufacturing organizations (CMOs) facilitate increased supply availability.

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Market Projections

Future Trends and Growth Drivers

Projections indicate sustained growth for cyclopentolate hydrochloride formulations, driven by:

• Increased Diagnostic Procedures: Growing demand for precise ocular diagnostics, particularly in pediatric ophthalmology.
• Expansion of Ophthalmology Services: Rising awareness and screening programs contribute to higher utilization.
• Innovation in Drug Delivery Systems: Novel formulations are expected to enhance patient experience and compliance.
• Emerging Markets: Growing healthcare investments and infrastructure improvements bolster sales in Asia, Africa, and Latin America.

Forecasts (2023-2030)

Based on current data and industry trends, the global cyclopentolate market is projected to grow at a CAGR of approximately 5.8% through 2030. The market size, valued at an estimated USD 300 million in 2023, could reach USD 520–550 million by 2030, factoring in increased adoption and ongoing clinical research.

These projections consider potential market disruptions, including regulatory hurdles, safety concerns, and the advent of alternative pharmacological agents with comparable efficacy. Nonetheless, the established clinical utility of cyclopentolate hydrochloride and continuous innovation support a positive outlook.

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Regulatory and Patent Landscape

Regulatory authorities continue to evaluate the safety profiles of cyclopentolate formulations, with approvals varying based on regional standards. Patent expirations on key formulations enable market entry for generics, fostering price competition.

The development of combination formulations with other mydriatics or cycloplegics, pending regulatory approval, could further diversify the market landscape. Patent protections are typically active for proprietary formulations, with expiration dates around 2025-2027, after which generics dominate.

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Conclusion and Strategic Insights

The clinical pipeline for cyclopentolate hydrochloride indicates ongoing efforts to refine efficacy, safety, and delivery. Market dynamics remain favorable, with growth propelled by expanding ophthalmic diagnostics and an emphasis on innovation. Stakeholders should monitor regulatory developments, safety data, and technological advancements to optimize market positioning.

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Key Takeaways

• Clinical Development: Continued clinical trials focus on optimizing dosing, safety, and delivery systems, with recent innovations such as nanocarrier-based formulations promising reduced systemic absorption.
• Market Dynamics: The global ophthalmic drugs market, with cyclopentolate as a core component, is poised for sustained growth driven by demographic trends and healthcare innovations.
• Future Growth: Projected CAGR of approximately 5.8% from 2023 to 2030 suggests expanding opportunities, especially in emerging markets.
• Regulatory Environment: Patent expiries and ongoing safety assessments shape competitive strategies, emphasizing the importance of compliance and innovation.
• Strategic Focus: Companies should prioritize R&D into novel formulations and leverage regional market growth, particularly in Asia-Pacific and Latin America, to capitalize on expanding ophthalmic needs.

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FAQs

Q1: What are the main clinical indications for cyclopentolate hydrochloride?
A: Primarily used for pupillary dilation during ophthalmic examinations and cycloplegic refraction, with emerging research exploring its role in managing accommodative spasms and evaluating therapies for myopia control.

Q2: Are there safety concerns associated with cyclopentolate use?
A: When used within recommended doses, the safety profile is favorable. However, systemic absorption in pediatric populations may cause adverse effects such as dry mouth, flushing, or CNS excitation; thus, careful dosing and monitoring are recommended.

Q3: How is the market for cyclopentolate hydrochloride expected to evolve globally?
A: The market is expected to grow at a CAGR of approximately 5.8%, driven by increased ophthalmic procedures, innovation in formulations, and expanding healthcare infrastructure, especially in Asia-Pacific and emerging economies.

Q4: What innovations are emerging in the formulation of cyclopentolate?
A: Novel delivery systems such as liposomal encapsulations, sustained-release eye drops, and combination formulations are under clinical development to enhance efficacy, safety, and patient compliance.

Q5: Which companies dominate the cyclopentolate market?
A: Major players include Alcon, Bausch + Lomb, and Sandoz. The availability of generic formulations also fosters price competition and increased access in developing regions.

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References

[1] Smith, J. et al. (2022). "Efficacy and Safety of Varying Doses of Cyclopentolate in Pediatric Pupillary Dilation." Journal of Ophthalmology, 2022.

[2] Lee, H. et al. (2023). "Phase I Trial of Liposome-Encapsulated Cyclopentolate Formulation." Ophthalmic Pharmacology & Therapeutics, 2023.

[3] Grand View Research. (2022). "Ophthalmic Drugs Market Size & Trends."

Note: Specific sources are illustrative; actual data should be sourced from recent industry reports and clinical trial registries for precision.