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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR PROPARACAINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Proparacaine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04515329 ↗ Tear Film Markers in Dry Eye Syndrome Not yet recruiting Sun Pharma Global FZE Phase 4 2020-09-01 Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
OTC NCT04515329 ↗ Tear Film Markers in Dry Eye Syndrome Not yet recruiting Vishal Jhanji Phase 4 2020-09-01 Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Proparacaine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00620997 ↗ Proparacaine vs Placebo for Corneal Injuries Completed London Health Sciences Centre Phase 1 2005-10-01 Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries. Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada. Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain. Patients were instructed to use the "study drug" on an "as-needed" basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected. The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.
NCT00656435 ↗ Bevacizumab and Long Acting Gas in Diabetic Vitrectomy Completed National Taiwan University Hospital Phase 3 2006-12-01 Persistent or recurrent vitreous hemorrhage after vitrectomy for diabetic retinopathy complications is a common occurrence with an incidence of 12% to 63%. This complication may prolong vitreous clear-up and delay visual rehabilitation significantly, and sometimes requires additional procedures or surgery. The causes of bleeding are diverse. Evidence suggests fibrovascular proliferation from the sclerotomy sites or from the vitreous base may be an important source of recurrent vitreous hemorrhage; other sources of bleeding include iatrogenic intraoperative injury of retinal vessels, and incomplete removal of fibrovascular tissues. We have reported on the possible benefit of peripheral retinal cryotherapy and cryotherapy treatment of sclerotomy sites to prevent delayed-onset recurrent vitreous hemorrhage, and the possible benefit of intravitreal long-acting gas to reduce the occurrence of early postoperative recurrent vitreous hemorrhage, especially for cases with active fibrovascular proliferation. However, minor recurrent vitreous hemorrhage and prolonged reabsorption of lysed blood clots from surgical trauma remain important factors to cause media opacity long enough to prevent quick visual rehabilitation. Intravitreal bevacizumab has been noted to induce rapid regression of retinal and iris neovascularization in proliferative diabetic retinopathy. Further, presurgical administration of intravitreal bevacizumab may reduce intraoperative bleeding during membrane dissection in PDR with traction retinal detachment. We hypothesize that presurgical treatment of intravitreal bevacizumab may reduce intraoperative bleeding and the amount of residual blood clots, while intraoperative infusion of long-acting gas may facilitate post-operative recovery of surgically injured retinal vessels. These combined effects would thus enhance early clear-up of vitreous opacity from clot lysis and recurrent retinal bleeding. To investigate this hypothesis, a clinical prospective study was undertaken to evaluate the effects of bevacizumab pretreatment combined with intravitreal infusion of long-acting gas on the clearance speed and the recurrence rate of early postoperative vitreous hemorrhage in vitrectomy for active diabetic fibrovascular proliferation.
NCT00769392 ↗ Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection Unknown status Lahey Clinic N/A 2008-09-01 This study is designed to compare four currently used types of anesthesia used for intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.
NCT01027611 ↗ Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections Completed Illinois Retina Associates Phase 3 2009-10-01 There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Proparacaine Hydrochloride

Condition Name

Condition Name for Proparacaine Hydrochloride
Intervention Trials
Diabetic Macular Edema 4
Age-related Macular Degeneration 3
Wet Macular Degeneration 2
Pain 2
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Condition MeSH

Condition MeSH for Proparacaine Hydrochloride
Intervention Trials
Macular Degeneration 7
Macular Edema 4
Retinopathy of Prematurity 2
Wet Macular Degeneration 2
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Clinical Trial Locations for Proparacaine Hydrochloride

Trials by Country

Trials by Country for Proparacaine Hydrochloride
Location Trials
United States 11
Canada 5
China 3
Israel 1
India 1
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Trials by US State

Trials by US State for Proparacaine Hydrochloride
Location Trials
Pennsylvania 3
Florida 2
Illinois 1
Massachusetts 1
New York 1
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Clinical Trial Progress for Proparacaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Proparacaine Hydrochloride
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Proparacaine Hydrochloride
Clinical Trial Phase Trials
Completed 9
Recruiting 6
Not yet recruiting 5
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Clinical Trial Sponsors for Proparacaine Hydrochloride

Sponsor Name

Sponsor Name for Proparacaine Hydrochloride
Sponsor Trials
McMaster University 2
Sun Yat-sen University 2
Sheba Medical Center 1
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Sponsor Type

Sponsor Type for Proparacaine Hydrochloride
Sponsor Trials
Other 40
Industry 1
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