Back to resultsPGE2 Levels in Patient Treated With NSAIDs
Primary Purpose
Ocular Inflammation
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Placebo
Dicloftil
Nevanac
Indom
Yellox
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation focused on measuring vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2
Eligibility 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
Sites / Locations
- Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Dicloftil
Nevanac
Indom
Yellox
Arm Description
Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery
Outcomes
Primary Outcome Measures
Vitreous NSAIDs and PGE2 levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03597867
Brief Title
PGE2 Levels in Patient Treated With NSAIDs
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trieste
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation
Keywords
vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
Arm Title
Dicloftil
Arm Type
Experimental
Arm Description
Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
Arm Title
Nevanac
Arm Type
Experimental
Arm Description
Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
Arm Title
Indom
Arm Type
Experimental
Arm Description
Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
Arm Title
Yellox
Arm Type
Experimental
Arm Description
Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tears
Intervention Description
Artificial tears for 3 days preoperatively
Intervention Type
Drug
Intervention Name(s)
Dicloftil
Other Intervention Name(s)
Diclofenac Na 0.1% Oph Soln
Intervention Description
Dosing of drug 3 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
Nevanac
Other Intervention Name(s)
Nepafenac 0.3% Ophthalmic Suspension
Intervention Description
Dosing of drug 3 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
Indom
Other Intervention Name(s)
Indomethacin 5 MG/ML Ophthalmic Suspension
Intervention Description
Dosing of drug 3 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
Yellox
Other Intervention Name(s)
Bromfenac 0.09 % Ophthalmic Solution
Intervention Description
Dosing of drug 3 days prior to surgery
Primary Outcome Measure Information:
Title
Vitreous NSAIDs and PGE2 levels
Time Frame
3 days after topical NSAID administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco R Pastore, MD
Organizational Affiliation
Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste
City
Trieste
State/Province
TS
ZIP/Postal Code
34129
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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PGE2 Levels in Patient Treated With NSAIDs
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