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Last Updated: June 2, 2020

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CLINICAL TRIALS PROFILE FOR TIMOLOL

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505(b)(2) Clinical Trials for Timolol

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
New Formulation NCT01426113 A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma Terminated Allergan Phase 3 2011-09-01 The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
New Formulation NCT02973880 Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Not yet recruiting Sintesi Research Srl Phase 3 2017-01-01 Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success. Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation. After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative. NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time. The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
New Formulation NCT02973880 Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Not yet recruiting SIFI SpA Phase 3 2017-01-01 Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success. Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation. After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative. NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time. The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Timolol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004641 A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients With Cirrhosis Completed Yale University Phase 2 1993-05-01 OBJECTIVES: I. Evaluate the efficacy of a certain drug in preventing intestinal complications in patients with cirrhosis and high blood pressure in the hepatic portal vein. II. Evaluate vein pressure measurements to predict the development of internal bleeding.
NCT00004641 A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients With Cirrhosis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 1993-05-01 OBJECTIVES: I. Evaluate the efficacy of a certain drug in preventing intestinal complications in patients with cirrhosis and high blood pressure in the hepatic portal vein. II. Evaluate vein pressure measurements to predict the development of internal bleeding.
NCT00006398 Prevention of Esophageal Varices by Beta-Adrenergic Blockers Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1993-08-01 The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00061542 Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension Completed Alcon Research Phase 3 2003-01-01 The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.
NCT00108017 Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2005-04-01 This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Timolol

Condition Name

Condition Name for Timolol
Intervention Trials
Ocular Hypertension 109
Glaucoma 68
Open-angle Glaucoma 38
Glaucoma, Open-Angle 18
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Condition MeSH

Condition MeSH for Timolol
Intervention Trials
Glaucoma 148
Ocular Hypertension 124
Hypertension 110
Glaucoma, Open-Angle 103
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Clinical Trial Locations for Timolol

Trials by Country

Trials by Country for Timolol
Location Trials
United States 322
Italy 22
Canada 21
Germany 20
Spain 14
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Trials by US State

Trials by US State for Timolol
Location Trials
California 30
Texas 21
Pennsylvania 18
Florida 16
New York 15
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Clinical Trial Progress for Timolol

Clinical Trial Phase

Clinical Trial Phase for Timolol
Clinical Trial Phase Trials
Phase 4 77
Phase 3 71
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Timolol
Clinical Trial Phase Trials
Completed 146
Recruiting 33
Unknown status 13
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Clinical Trial Sponsors for Timolol

Sponsor Name

Sponsor Name for Timolol
Sponsor Trials
Alcon Research 37
Allergan 35
Pfizer 14
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Sponsor Type

Sponsor Type for Timolol
Sponsor Trials
Industry 152
Other 97
U.S. Fed 3
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