Last Updated: November 8, 2026

CLINICAL TRIALS PROFILE FOR BENOXINATE HYDROCHLORIDE

« Back to Dashboard


All Clinical Trials for BENOXINATE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01361841 ↗ Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma Unknown status Centre de recherche du Centre hospitalier universitaire de Sherbrooke N/A 2009-01-01 Intraocular pressure (IOP) is considered to be the main risk factor for progression of glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has changed considerably during the last decades due to the introduction of prostaglandin analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan). There have been several studies to evaluate their effectiveness. The three seem to be equivalent, according to the only study that has compared the molecules. Latanoprost is employed initially, due to its paucity of side effects when compared to the other two analogues. However, if it is not effective, several studies ahve shown that a result is possible using either travoprost or bimatoprost. No study has been conducted to date systematically comparing the three molecules in cases of resistance to latanoprost. In actuality, the investigators patients will receive treatment identical to current practice with the exception of the group continuing with latanoprost. Several studies confirm the benefit of changing prostaglandin analogues if the first has not signficantly decreased the IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects) The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and travoprost in their IOP-lowering capacity in patients who do not initially respond to latanoprost.
NCT03243500 ↗ Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery Completed Kasr El Aini Hospital Phase 4 2015-05-01 There are several local anesthetic techniques available for cataract surgery and the choice depends on patient, surgical and operator factors. The eyes of patients with axial myopia (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle insertion for local anesthetic injection between the globe and the orbit and out-pouching of the back of the eye (staphyloma). These factors increased the risk of perforation following conventional needle techniques of eye block The current study technique is per-caruncular injection (the needle insertion site is between the nasal side of the globe and bony orbit) which may provide a safer alternative to the conventional needle techniques for myopic patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are infrequently located on the nasal side of the globe. Local injection of muscle relaxant added to local anesthetic solution may provide earlier onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local anesthetic solution alone. The current study will demonstrate the effect of adding low dose atracurium (a muscle relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and favorable surgical condition in per-caruncular technique of eye block in high myopes undergoing cataract surgery.
NCT05033106 ↗ Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity Recruiting Cairo University Phase 3 2020-09-01 Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
NCT05033106 ↗ Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity Recruiting Zagazig University Phase 3 2020-09-01 Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
NCT05666362 ↗ HEMODYNAMIC RESPONSE OTO PAIN DURING RETINOPATHY OF PREMATURITY SCREENING Recruiting Alexandria University N/A 2022-03-20 Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.
NCT05926258 ↗ Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population Not yet recruiting Cross Research S.A. Phase 3 2024-05-10 The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients. 74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia. The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BENOXINATE HYDROCHLORIDE

Condition Name

Condition Name for BENOXINATE HYDROCHLORIDE
Intervention Trials
Quality of Ocular Akinesia (Onset and Duration) 1
Retinal Vein Occlusion (RVO) 1
Cornea Disease 1
Retinopathy of Prematurity 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for BENOXINATE HYDROCHLORIDE
Intervention Trials
Retinopathy of Prematurity 3
Corneal Diseases 1
Retinal Diseases 1
Premature Birth 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for BENOXINATE HYDROCHLORIDE

Trials by Country

Trials by Country for BENOXINATE HYDROCHLORIDE
Location Trials
Egypt 5
Brazil 1
Canada 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for BENOXINATE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BENOXINATE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE3 2
Phase 4 1
Phase 3 2
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for BENOXINATE HYDROCHLORIDE
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Unknown status 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for BENOXINATE HYDROCHLORIDE

Sponsor Name

Sponsor Name for BENOXINATE HYDROCHLORIDE
Sponsor Trials
Alexandria University 2
Zagazig University 1
Cross Research S.A. 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for BENOXINATE HYDROCHLORIDE
Sponsor Trials
Other 8
Industry 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Benoxinate Hydrochloride (Topical Ophthalmic Anesthetic)

Last updated: May 11, 2026

Benoxinate hydrochloride is a topical ocular local anesthetic used to reduce pain during ophthalmic procedures and in select diagnostic settings. Public clinical-trials and market data are sparse at the level needed for a decision-grade projection. No complete, verifiable set of FDA status, late-stage development timelines, active registrational trials, and revenue benchmarks is available in the record provided here, so a complete market forecast and probability-weighted competitive launch scenario cannot be produced.

What clinical trials are ongoing for benoxinate hydrochloride?

Answer: No ongoing, trial-level, publicly verifiable clinical development program can be confirmed from the information available in this session.

Are there Phase 3 or registrational trials for benoxinate hydrochloride?

Answer: No Phase 3/registrational trial set can be confirmed for benoxinate hydrochloride.

What indications are being tested (ocular procedures, diagnostics, pain relief)?

Answer: No indication-level trial map can be confirmed from the information available here.

Which sponsors are running benoxinate hydrochloride studies?

Answer: No sponsor list can be confirmed.

What are the trial designs (randomized, controlled, endpoints)?

Answer: No design details can be confirmed.

How is benoxinate hydrochloride used commercially in ophthalmology and where does demand come from?

Answer: Commercial use centers on procedural topical anesthesia for ophthalmic exams and minor procedures. Demand is driven by procedure volumes, payer patterns, and formulary inclusion for ophthalmic anesthetic drops.

What settings drive utilization?

Common use cases include corneal epithelial disruption procedures and ophthalmic diagnostic work where topical anesthesia is required. A decision-grade decomposition by setting cannot be completed from the information available here.

Which delivery form factors exist (drops, concentrations)?

Answer: Concentration and formulation breadth cannot be validated in this session.

What payer and channel dynamics matter most?

Answer: Benoxinate’s pricing and volume exposure typically track institutional and retail ophthalmic supply chains. A quantified channel split cannot be produced from the information available here.

What is the current market size for benoxinate hydrochloride and topical ophthalmic anesthetics?

Answer: A verified market-size figure and segment breakdown cannot be produced from the information available in this session.

How large is the topical ophthalmic anesthetic category?

Answer: Category sizing cannot be validated here.

What share is benoxinate likely to capture vs lidocaine, tetracaine, proparacaine?

Answer: Competitive share cannot be validated here.

When does benoxinate hydrochloride face exclusivity or generic entry pressure?

Answer: A decision-grade exclusivity and generic-forecast timeline cannot be produced because Orange Book listing dates, patent estates, and FDA approval history are not available in this session.

Does benoxinate hydrochloride have Orange Book exclusivity or listed patents?

Answer: Status cannot be confirmed here.

What is the Paragraph IV risk for benoxinate hydrochloride?

Answer: Paragraph IV risk cannot be evaluated here without ANDA/BLA docket information.

What patent estates would likely constrain substitution?

Answer: A patent-by-patent assessment cannot be produced from the information available here.

What FDA regulatory status applies to benoxinate hydrochloride (NDA, ANDA, OTC, labelling)?

Answer: FDA status cannot be confirmed from the information available here.

Is it Rx-only or OTC in key markets?

Answer: Regulatory classification cannot be confirmed.

What is the approval pathway (NDA vs ANDA) and reference product history?

Answer: Not determinable here.

How strong is the patent estate for benoxinate hydrochloride and its formulations?

Answer: Patent strength cannot be assessed here without patent and Orange Book data.

What formulations or method-of-use patents protect benoxinate hydrochloride?

Answer: Not determinable here.

Which jurisdictions matter for enforcement (US, EU, UK, Canada)?

Answer: Not determinable here.

Which companies sell benoxinate hydrochloride and how intense is price competition?

Answer: A competitor roster and price-competition intensity cannot be validated here.

What are the likely leading suppliers in ophthalmic generics?

Answer: Not determinable here.

What substitutability exists versus alternative topical anesthetics?

Answer: Substitutability is clinically plausible within the class, but a quantified switch-cost and substitution elasticity cannot be produced here.

Market projection: revenue outlook, adoption drivers, and downside risks

Answer: A probability-weighted revenue projection for benoxinate hydrochloride cannot be produced from the information available in this session because verified inputs are missing: (1) current sales basis, (2) regulatory and patent timeline, (3) competitor entry schedule, and (4) clinical development milestones.

Upside drivers

  • Stable or rising ophthalmic procedure volumes (especially anterior segment care)
  • Formulary stability and institutional contracting

Downside risks

  • Increased generic erosion and net price compression
  • Substitution to alternative anesthetics with better access or contracting terms

Base-case and scenario plan

A quantified base-case, bull case, and bear case cannot be produced here.

Key Takeaways

  • Benoxinate hydrochloride is a topical ocular anesthetic used for ophthalmic procedures and diagnostics, but decision-grade clinical-trial, regulatory, and market data are not available in the record provided here.
  • No verifiable ongoing clinical trials (Phase 2/3/registrational) or specific sponsors can be confirmed for benoxinate hydrochloride from this session.
  • A quantitative market-size figure and revenue projection cannot be produced without validated FDA status, current sales benchmarks, and patent/exclusivity timelines.

FAQs

  1. Is benoxinate hydrochloride still used in routine ophthalmic examinations and procedures?
  2. How does benoxinate hydrochloride compare with tetracaine, proparacaine, and lidocaine for topical corneal anesthesia?
  3. Are there any known clinical safety signals unique to benoxinate hydrochloride in ophthalmic use?
  4. What generic substitution risks exist for benoxinate hydrochloride in the US market?
  5. What FDA regulatory pathway typically applies to older topical ophthalmic anesthetic products like benoxinate hydrochloride?

References

  1. No citable sources were available in the information provided in this session.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.