Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

Phase 4

Completed

• Conditions: Inflammation
• Interventions: Drug: Ketorolac 0.4%; Drug: Lubricating Eye Drop

• Registration Number: NCT00791323
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-14
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2011-08-17
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-21
• Last Update Submitted: 2011-09-21
• Results First Posted: 2011-09-23
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria

• History of intraocular surgery in the operative eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ketorolac 0.4%	Ketorolac 0.4%
2	Lubricating Eye Drop	Mineral Oil Emollient

Primary Outcome Measures

Name	Time	Method
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels	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).