ClinicalTrials.gov
ClinicalTrials.gov Menu

NSAIDs and PGE2 Levels in Vitrectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02361645
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Russo, Università degli Studi di Brescia

Brief Summary:

The purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy.

A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R & D Systems, Minneapolis, MN).


Condition or disease Intervention/treatment Phase
Vitreous Inflammation Drug: Ketorolac 0.5% eyedrops Drug: Indomethacin 0.5% eyedrops Drug: Bromfenac 0.09% eyedrops Drug: Nepafenac 0.1% eyedrops Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
No NSAIDs were administered prior to surgery
Experimental: Ketorolac eyedrops
Ketorolac 0.5% eyedrops were administered prior to surgery
Drug: Ketorolac 0.5% eyedrops
Experimental: Indomethacin eyedrops
Indomethacin 0.5% eyedrops were administered prior to surgery
Drug: Indomethacin 0.5% eyedrops
Experimental: Nepafenac eyedrops
Nepafenac 0.1% eyedrops were administered prior to surgery
Drug: Nepafenac 0.1% eyedrops
Experimental: Bromfenac eyedrops
Bromfenac 0.09% eyedrops were administered prior to surgery
Drug: Bromfenac 0.09% eyedrops



Primary Outcome Measures :
  1. Prostaglandin E2 levels in the vitreous (pg/mL) [ Time Frame: 7 days after NSAID TID administration, following vitrectomy ]

Secondary Outcome Measures :
  1. NSAIDs concentration (ng/mL) into the vitreous [ Time Frame: 7 days after NSAID TID administration, following vitrectomy ]
    Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system.

  2. Adverse events [ Time Frame: 7 days after NSAID TID administration, following vitrectomy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with pucker scheduled for vitrectomy

Exclusion Criteria:

  • diabetes
  • active inflammation

Responsible Party: Andrea Russo, PhD Candidate, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02361645     History of Changes
Other Study ID Numbers: Vitreo001
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Andrea Russo, Università degli Studi di Brescia:
nonsteroidal antiinflammatory drugs
prostaglandin E2
vitrectomy

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Ketorolac
Ketorolac Tromethamine
Indomethacin
Nepafenac
Bromfenac
Anti-Inflammatory Agents
Tetrahydrozoline
Dinoprostone
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents