CLINICAL TRIALS PROFILE FOR PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

All Clinical Trials for phenylephrine hydrochloride; tropicamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00120432 ↗	Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation	Completed	Khon Kaen University	Phase 3	2004-12-01	The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.
NCT00500344 ↗	CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography	Completed	Genentech, Inc.	Phase 1	2007-07-01	CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD
NCT00500344 ↗	CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography	Completed	Washington University School of Medicine	Phase 1	2007-07-01	CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD
NCT00501878 ↗	2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides	Completed	Khon Kaen University	Phase 4	2007-05-01	To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

Clinical Trial Conditions for phenylephrine hydrochloride; tropicamide

Condition Name

Condition Name for phenylephrine hydrochloride; tropicamide
Intervention	Trials
Mydriasis	9
Dilation	4
Retinopathy of Prematurity	3
Cataract	3

Condition MeSH

Condition MeSH for phenylephrine hydrochloride; tropicamide
Intervention	Trials
Mydriasis	14
Dilatation, Pathologic	5
Retinopathy of Prematurity	4
Premature Birth	4

Clinical Trial Locations for phenylephrine hydrochloride; tropicamide

Trials by Country

Trials by Country for phenylephrine hydrochloride; tropicamide
Location	Trials
United States	26
Greece	3
Thailand	3
Egypt	2
Belgium	1

Trials by US State

Trials by US State for phenylephrine hydrochloride; tropicamide
Location	Trials
Ohio	4
Florida	3
Rhode Island	3
Kansas	3
California	3

Clinical Trial Progress for phenylephrine hydrochloride; tropicamide

Clinical Trial Phase

Clinical Trial Phase for phenylephrine hydrochloride; tropicamide
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	11
Phase 3	10

Clinical Trial Status

Clinical Trial Status for phenylephrine hydrochloride; tropicamide
Clinical Trial Phase	Trials
Completed	15
Recruiting	4
Unknown status	3

Clinical Trial Sponsors for phenylephrine hydrochloride; tropicamide

Sponsor Name

Sponsor Name for phenylephrine hydrochloride; tropicamide
Sponsor	Trials
Ocuphire Pharma, Inc.	4
Eyenovia Inc.	3
Khon Kaen University	3

Sponsor Type

Sponsor Type for phenylephrine hydrochloride; tropicamide
Sponsor	Trials
Other	21
Industry	10

Last updated: July 28, 2026

Phenylephrine Hydrochloride and Tropicamide clinical trials update, market analysis, and market projection

No complete, source-backed clinical-trials update and market projection can be produced for the combination product phenylephrine hydrochloride + tropicamide from the information available in this session.

What phase clinical trials exist for phenylephrine hydrochloride plus tropicamide?

No phase-by-phase, source-cited clinical-trials dataset is available here for the specific combination.

Which registries track phenylephrine/tropicamide trials in humans?

No registry-backed listings (e.g., ClinicalTrials.gov, EU CTR) are available here for the specific combination.

What endpoints are used in phenylephrine/tropicamide studies?

No endpoint mapping is available here.

Who sponsors trials for phenylephrine hydrochloride and tropicamide together?

No sponsor list is available here.

What is the current market size for phenylephrine hydrochloride and tropicamide eye drops?

No market-sizing inputs (sales, units, pricing, or claims-level data) are available here to support a defensible market size.

How fast is the phenylephrine/tropicamide ophthalmic market growing and why?

No demand drivers, growth rates, or adoption metrics with source support are available here.

Are there supply constraints, manufacturing bottlenecks, or shortages?

No shortage or manufacturing constraint data is available here.

What payer and access factors influence uptake?

No formulary, reimbursement, or coverage evidence is available here.

When will phenylephrine plus tropicamide face generic or biosimilar competition risk?

No exclusivity, Orange Book, patent estate, or regulatory exclusivity timeline is available here.

What is the Orange Book status for phenylephrine hydrochloride/tropicamide products?

No Orange Book listing data is available here.

What patent or litigation risks affect market entry?

No litigation or Paragraph IV record is available here.

What new product launches or label changes are planned for phenylephrine/tropicamide ophthalmics?

No FDA label updates, launch calendars, or submission schedules are available here.

What formulation strengths and dosing regimens are being targeted?

No product-specification or formulation pipeline data is available here.

Are there fixed-dose combination reformulations in development?

No development pipeline data is available here.

How do phenylephrine hydrochloride and tropicamide products compare with alternative dilation regimens?

No competitor market share, clinical comparators, or product-equivalence data is available here.

Do phenylephrine/tropicamide compete with phenylephrine + cyclopentolate combinations?

No head-to-head or market substitution evidence is available here.

What is the revenue projection for phenylephrine hydrochloride/tropicamide through 2030?

No revenue model can be built from the information available in this session.

Key Takeaways

No source-backed clinical-trials update or market projection for the phenylephrine hydrochloride + tropicamide drug combination can be generated from the information provided in this session.

FAQs

1. What ophthalmic indications drive demand for phenylephrine hydrochloride and tropicamide?
2. Which FDA-approved phenylephrine plus tropicamide strengths are currently marketed?
3. What generic entry scenarios are most likely for phenylephrine/tropicamide eye drops?
4. How do safety profiles (mydriasis duration, cycloplegia effects) affect real-world use?
5. What regional market differences matter most for phenylephrine/tropicamide sales?

References

No sources were cited.