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NCT00521456 Clinical Trial

A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Cataract Extraction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00521456
Other study ID # 191578-006
Secondary ID
Status Completed
Phase Phase 3
First received August 23, 2007
Last updated September 29, 2009
Start date October 2007
Est. completion date March 2008

Study information
Verified date August 2009
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery

Recruitment information / eligibility
Status Completed
Enrollment 263
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing cataract surgery

Exclusion Criteria:

- Uncontrolled ocular disease in cataract surgery eye

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:
• ketorolac eye drops
1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution of Post Operative Inflammation Day 14 No
Secondary Ocular Pain Day 1 No
Secondary Mean Pupil Area Day 0 No
See also
  Status Clinical Trial Phase
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Completed NCT00565695 - Evaluation of the Aspheric ReSTOR Intraocular Lens (IOL) After Routine Cataract Extraction N/A
Completed NCT00524264 - A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery Phase 3
Completed NCT02973880 - Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Phase 3
Completed NCT00721695 - Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification. Phase 1/Phase 2
Withdrawn NCT00466908 - Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
Completed NCT00366665 - Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems N/A
Completed NCT05571683 - Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection
Not yet recruiting NCT04977115 - Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract N/A
Withdrawn NCT00366613 - Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation Phase 4
Completed NCT00366496 - Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens N/A
Not yet recruiting NCT03828500 - Preoperative Fasting for Ambulatory Cataract Surgery: The PRACTICE Study N/A
Completed NCT00840580 - Effect on Wound Healing of Vigamox Versus Cravit Phase 4
Completed NCT00842231 - Assessment of Visual Performance in Patients With Low Levels of Astigmatism N/A
Completed NCT00851760 - Epiretinal Macular Membrane and Cataract Extraction N/A
Recruiting NCT03944070 - Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery N/A
Completed NCT03364972 - A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 N/A
Completed NCT00824070 - Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects Phase 1
Completed NCT00366691 - Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation Phase 4
Completed NCT00366405 - Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification Phase 4

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