Clinical Trials Logo
  1. Home
  2. Pain
  3. NCT00333918
  4. Details
NCT00333918 Clinical Trial

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Pain Clinical Trial

Official title:
Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333918
Other study ID # ISTA-BR-CS02
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2006
Last updated February 13, 2013
Start date June 2006
Est. completion date March 2007

Study information
Verified date February 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 primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Recruitment information / eligibility
Status Completed
Enrollment 522
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery

- Agree to return for all required visits

- Agree to avoid disallowed medications

Exclusion Criteria:

- Known hypersensitivity to bromfenac and salicylates

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bromfenac ophthalmic solution

• placebo comparator

Locations
Country Name City State
n/a

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 Reduction of ocular inflammation No
Secondary Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care