Clinical Trials Logo
  1. Home
  2. Postoperative Complications
  3. NCT00198523
  4. Details
NCT00198523 Clinical Trial

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Postoperative Complications Clinical Trial

Official title:
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198523
Other study ID # ISTA-TP-CPK01
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 13, 2013
Start date July 2005
Est. completion date October 2005

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Bilateral cataract surgery

- Avoid disallowed medications throughout study

Exclusion Criteria:

- Contraindications to the use of the test agents

- Known allergy or sensitivity to the test agents or components

- History of steroid response following topical administration of corticosteroids in the eye

- Wore contact lenses 48 hours prior to Visit 1

- An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye

- Any significant illness that could be expected to interfere with study

- Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisolone and Tobramycin

• Prednisolone

Locations
Country Name City State
United States Texan Eye Care PA Austin Texas
United States Cornea Consultants/Laser Eye Consultants of Boston Boston Massachusetts
United States Donald E. Beahm, MD Great Bend Kansas
United States Houston Eye Associates Houston Texas
United States Eyesight Ophthalmic Services, PA Portsmouth New Hampshire
United States Great Lakes Eye Care St. Joseph Michigan

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points Comparison of aqueous humor concentrations of prednisolone acetate at various time points 2 days No
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3