Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

• ClinicalTrials.gov Identifier: NCT00791323
• Recruitment Status: Completed
• First Posted: November 14, 2008
• Results First Posted: September 23, 2011
• Last Update Posted: September 23, 2011
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: November 12, 2008
• First Posted Date: November 14, 2008
• Results First Submitted Date: August 17, 2011
• Results First Posted Date: September 23, 2011
• Last Update Posted Date: September 23, 2011
• Study Start Date: November 2008
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2011)

Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels [ Time Frame: Day 3 ]

The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).

• Original Primary Outcome Measures (submitted: November 12, 2008): Mean PGE2 aqueous levels [ Time Frame: Day 3 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
• Official Title: Not Provided
• Brief Summary: A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Inflammation

Intervention

• Drug: Ketorolac 0.4%
  One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
  Other Name: Acular LS™
• Drug: Lubricating Eye Drop
  One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
  Other Name: Soothe® XP

Study Arms

• Active Comparator: 1
  Ketorolac 0.4%
  Intervention: Drug: Ketorolac 0.4%
• Active Comparator: 2
  Mineral Oil Emollient
  Intervention: Drug: Lubricating Eye Drop

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2011): 9
• Original Estimated Enrollment (submitted: November 12, 2008): 15
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

• History of intraocular surgery in the operative eye

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00791323
• Other Study ID Numbers: MA-ACU-08-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Allergan
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Allergan

• PRS Account: Allergan
• Verification Date: September 2011