CLINICAL TRIALS PROFILE FOR ATROPINE

All Clinical Trials for Atropine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	National Eye Institute (NEI)	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	Jaeb Center for Health Research	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000333 ↗	Evaluation of Benztropine for Cocaine Craving - 2	Completed	Washington D.C. Veterans Affairs Medical Center	Phase 2	2001-05-01	The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.
NCT00000333 ↗	Evaluation of Benztropine for Cocaine Craving - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2001-05-01	The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.
NCT00001864 ↗	Amblyopia (Lazy Eye) Treatment Study	Completed	National Eye Institute (NEI)	Phase 3	1999-05-01	The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for some reason, such as crossing or turning out of the eyes, and vision in the weak eye is reduced. Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this: 1) a patch placed over the "good" eye forces the child to use the weak eye; or 2) an eye drop placed in the "good" eye once a day to blur vision in that eye makes the child rely on the weak eye. The success rates with both of these methods have been reported to be about the same; this study will try to identify if one is more effective than the other. Children will be randomly assigned by computer to one of the following two treatment methods: Patch The child initially will wear a patch over the "good" eye for 8 to 12 hours every day. If vision in the weak eye improves, the patching time will be decreased. If vision remains good after 3 months, the patching will be stopped, unless the child's doctor believes treatment should continue. If vision in the weak eye does not improve, the patching time will be increased. Eye Drops The child will be given one drop per day of atropine in the "good" eye. If vision in the weak eye improves, the drops will be given less often. If the vision remains good after 3 months, the drops will be stopped, unless the child's doctor believes treatment should continue. If the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses may be changed to try to further blur the vision in the "good" eye. After 6 months, treatment may be stopped if it has not been successful. If treatment has been successful after 6 months, it may be continued at a reduced amount or stopped. Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4 months after that until the end of the 2-year study. During each visit the eyes will be examined for eye movements and vision, and the pupils will be dilated to examine the inside of the eye.
NCT00094614 ↗	Trial Comparing Daily Atropine Versus Weekend Atropine	Completed	National Eye Institute (NEI)	Phase 4	2002-06-01	The goals of this study are: - To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine. - To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.

Clinical Trial Conditions for Atropine

Condition Name

Condition Name for Atropine
Intervention	Trials
Myopia	33
Anesthesia	27
Postoperative Pain	21
Hypotension	14

Condition MeSH

Condition MeSH for Atropine
Intervention	Trials
Myopia	44
Pain, Postoperative	38
Hypotension	34
Vomiting	17

Clinical Trial Locations for Atropine

Trials by Country

Trials by Country for Atropine
Location	Trials
Egypt	108
United States	93
China	28
Turkey	25
Brazil	12

Trials by US State

Trials by US State for Atropine
Location	Trials
Texas	10
California	10
Maryland	9
New York	7
Ohio	5

Clinical Trial Progress for Atropine

Clinical Trial Phase

Clinical Trial Phase for Atropine
Clinical Trial Phase	Trials
Phase 4	137
Phase 3	47
Phase 2/Phase 3	16

Clinical Trial Status

Clinical Trial Status for Atropine
Clinical Trial Phase	Trials
Completed	204
Recruiting	76
Not yet recruiting	59

Clinical Trial Sponsors for Atropine

Sponsor Name

Sponsor Name for Atropine
Sponsor	Trials
Assiut University	16
Ain Shams University	14
Mansoura University	14

Sponsor Type

Sponsor Type for Atropine
Sponsor	Trials
Other	508
Industry	27
NIH	16

Atropine: Clinical Trials, Market Analysis, and Projections

Introduction to Atropine

Atropine, a derivative of the belladonna plant, is a versatile medication with a wide range of medical applications. It is used in ophthalmology, anesthesia, and as an antidote for organophosphate poisoning, among other uses. This article will delve into recent clinical trials, market analysis, and projections for atropine.

Clinical Trials Update

Myopia Control with Atropine

Recent clinical trials have focused on the efficacy of atropine in controlling myopia progression in children. A randomized clinical trial published in 2023 investigated the use of 0.01% atropine eye drops in US children aged 5 to 12 years. The study involved 187 children, with 125 receiving atropine and 62 receiving a placebo. The results showed that atropine did not significantly slow myopia progression or axial elongation compared to the placebo group over a 24-month period[1].

In contrast, a study using 0.03% atropine eye drops found that this concentration was effective in slowing myopia progression. The study, which involved 31 patients in the atropine group and 41 in the control group, showed a significant reduction in spherical equivalent (SE) and axial length (AL) in the atropine group after one year of treatment[4].

Market Analysis

Global Atropine Market Size and Projections

The global atropine market is experiencing significant growth driven by various factors. As of 2023, the atropine sulfate market was valued at USD 100 million and is projected to reach USD 147.7 million by 2031, growing at a CAGR of 5% from 2024 to 2031[2].

Key Drivers of Market Growth

Several factors are driving the expansion of the atropine market:

• Increasing Surgical Procedures: The rise in surgical operations worldwide has increased the demand for atropine as a preoperative drug to manage bradycardia and other conditions[2][5].
• Growing Prevalence of Chronic Diseases: The increasing incidence of cardiovascular disorders, ocular disorders, and other chronic conditions has boosted the demand for atropine in emergency care and other medical applications[3][5].
• Advancements in Drug Delivery: Innovations in drug formulation and delivery systems have enhanced the efficacy and availability of atropine, contributing to market growth[2][5].
• Rising Healthcare Investments: Growing investments in healthcare infrastructure and emergency response systems are also driving the market forward[3][5].

Market Segments and Competitive Landscape

The atropine market can be segmented based on product type, application, and end-use. Key applications include ophthalmology, anesthesia, and treatment of organophosphate poisoning. The competitive landscape is characterized by a few major players, with market entry barriers for new entrants due to stringent regulatory frameworks[2][3].

Market Projections

Atropine Sulfate Injection Market

The Atropine Sulfate Injection Market was valued at USD 0.91 billion in 2022 and is projected to reach USD 1.28 billion by 2030, growing at a CAGR of 4.4% from 2024 to 2030. This growth is driven by the increasing demand for anticholinergic drugs in emergency medicine, ophthalmology, and the treatment of organophosphate poisoning[5].

Global Atropine Market Forecast

The global atropine market is expected to register rapid growth over the forecast period of 2021 to 2028, driven by factors such as increasing healthcare spending, advancements in healthcare technology, and the growing adoption of precision medicine[3].

Challenges and Opportunities

Challenges

Despite the growth prospects, the atropine market faces several challenges:

• Adverse Side Effects: Atropine is associated with adverse side effects and contraindications, which can limit its use in certain patient populations[5].
• Regulatory Barriers: Stringent regulatory frameworks pose barriers to market entry for new players[5].
• Competition from Alternatives: The market also faces competition from alternative treatments and medications[5].

Opportunities

• Growing Geriatric Population: The increasing geriatric population with a higher incidence of medical conditions requiring atropine treatment presents a significant opportunity for market growth[5].
• Innovation in Drug Delivery: Continued innovations in drug delivery systems and formulations can enhance the therapeutic effectiveness of atropine, further boosting market growth[2][5].

Key Takeaways

• Clinical Trials: Recent trials have shown mixed results for atropine in controlling myopia, with 0.01% atropine eye drops being ineffective but 0.03% showing promise.
• Market Growth: The global atropine market is expected to grow significantly, driven by increasing surgical procedures, growing prevalence of chronic diseases, and advancements in drug delivery.
• Market Projections: The Atropine Sulfate Injection Market and the broader atropine market are projected to grow at CAGRs of 4.4% and 5%, respectively, over the forecast periods.
• Challenges and Opportunities: The market faces challenges such as adverse side effects and regulatory barriers but also presents opportunities due to the growing geriatric population and innovations in drug delivery.

FAQs

What is the current status of atropine in controlling myopia?

Atropine's efficacy in controlling myopia is mixed. A 0.01% concentration did not show significant benefits, while a 0.03% concentration has been shown to slow myopia progression[1][4].

What are the primary drivers of the atropine market growth?

The primary drivers include increasing surgical procedures, growing prevalence of chronic diseases, advancements in drug delivery, and rising healthcare investments[2][3][5].

What are the projected market values for atropine by 2031?

The Atropine Sulfate Market is projected to reach USD 147.7 million by 2031, and the Atropine Sulfate Injection Market is expected to reach USD 1.28 billion by 2030[2][5].

What are the main challenges facing the atropine market?

The main challenges include adverse side effects, regulatory barriers, and competition from alternative treatments[5].

How is the growing geriatric population impacting the atropine market?

The growing geriatric population with a higher incidence of medical conditions requiring atropine treatment is presenting a significant opportunity for market growth[5].

Sources

1. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control. JAMA Ophthalmology, 2023.
2. Atropine Sulfate Market Size and Projections. Market Research Intellect.
3. Atropine Market Growth 2022-2028. Biospace.
4. Efficacy and Safety of 0.03% Atropine Eye Drops in Controlling Myopia. MDPI.
5. Atropine Sulfate Injection Market. GitHub.