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PGE2 Levels in Patient Treated With NSAIDs

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: NCT03597867
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Marco Rocco Pastore, University of Trieste

Study Description
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Brief Summary:

The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.

All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.

Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.

PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.


Condition or disease Intervention/treatment Phase
Ocular Inflammation Other: Placebo Drug: Dicloftil Drug: Nevanac Drug: Indom Drug: Yellox Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nepafenac

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
 Other: Placebo
Artificial tears for 3 days preoperatively
Other Name: Tears
Experimental: Dicloftil
Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
 Drug: Dicloftil
Dosing of drug 3 days prior to surgery
Other Name: Diclofenac Na 0.1% Oph Soln
Experimental: Nevanac
Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
 Drug: Nevanac
Dosing of drug 3 days prior to surgery
Other Name: Nepafenac 0.3% Ophthalmic Suspension
Experimental: Indom
Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
 Drug: Indom
Dosing of drug 3 days prior to surgery
Other Name: Indomethacin 5 MG/ML Ophthalmic Suspension
Experimental: Yellox
Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery
 Drug: Yellox
Dosing of drug 3 days prior to surgery
Other Name: Bromfenac 0.09 % Ophthalmic Solution


Outcome Measures
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Primary Outcome Measures :
  1. Vitreous NSAIDs and PGE2 levels [ Time Frame: 3 days after topical NSAID administration ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion Criteria:

  • vitreous hemorrhage
  • diabetes
  • glaucoma
  • concurrent retinovascular disease
  • previous ocular inflammation
  • previous ocular surgery
  • history of ocular trauma
  • previuos intravitreal injections
  • concomitant intake of topical or systemic NSAIDs or corticosteroid therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597867


Locations
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Italy
Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste
Trieste, TS, Italy, 34129
Sponsors and Collaborators
University of Trieste
Investigators
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Principal Investigator: Marco R Pastore, MD Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy
More Information
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Responsible Party: Marco Rocco Pastore, Principal Investigator, University of Trieste
ClinicalTrials.gov Identifier: NCT03597867    
Other Study ID Numbers: 02/2017
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Rocco Pastore, University of Trieste:
vitreoretinal surgery
epiretinal membrane
macular hole
non steroidal antinflammatory drugs
prostaglandin E2
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Diclofenac
Indomethacin
Nepafenac
Bromfenac
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents