Ocular InflammationPhase 3NCT03597867
PGE2 Levels in Patient Treated With NSAIDs
A Phase 3 study testing Dicloftil, Nevanac and Indom in people with Ocular Inflammation, run by University of Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Inflammation
- What is being tested?
- Dicloftil, Nevanac and Indom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 25 Apr 2018to 9 Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- epiretinal membrane or full thickness macular hole scheduled for vitrectomy
Who cannot join
- vitreous hemorrhage
- diabetes
- glaucoma
- concurrent retinovascular disease
- previous ocular inflammation
- previous ocular surgery
Show all 9Show fewer
- history of ocular trauma
- previuos intravitreal injections
- concomitant intake of topical or systemic NSAIDs or corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste
Trieste, TS, 34129
About this study
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
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.
- Conditions
- Ocular Inflammation
- Being tested
- Placebo, Dicloftil, Nevanac, Indom, Yellox
- Keywords
- vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Tears
Artificial tears for 3 days preoperatively
DicloftilDrug
Also called Diclofenac Na 0.1% Oph Soln
Dosing of drug 3 days prior to surgery
NevanacDrug
Also called Nepafenac 0.3% Ophthalmic Suspension
Dosing of drug 3 days prior to surgery
IndomDrug
Also called Indomethacin 5 MG/ML Ophthalmic Suspension
Dosing of drug 3 days prior to surgery
YelloxDrug
Also called Bromfenac 0.09 % Ophthalmic Solution
Dosing of drug 3 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery. Receives: Other: Placebo |
| Dicloftil | Experimental | Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery Receives: Drug: Dicloftil |
| Nevanac | Experimental | Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery Receives: Drug: Nevanac |
| Indom | Experimental | Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery Receives: Drug: Indom |
| Yellox | Experimental | Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery Receives: Drug: Yellox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitreous NSAIDs and PGE2 levels
Measured: 3 days after topical NSAID administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start25 Apr 2018
- Primary completion5 Jul 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Rocco Pastore, University of Trieste
- Investigators
- Marco R Pastore, MD, Principal investigator, Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597867
- Sponsor's protocol ID
- 02/2017
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03597867
- Acronym / sponsor ID
- 02/2017
- Conditions
- Ocular Inflammation
- Keywords
- vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery. |
| Dicloftil | Experimental | Drug: DicloftilDiclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery |
| Nevanac | Experimental | Drug: NevanacNepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery |
| Indom | Experimental | Drug: IndomIndomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery |
| Yellox | Experimental | Drug: YelloxBromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- epiretinal membrane or full thickness macular hole scheduled for vitrectomy
Key exclusion criteria (9 listed)
- vitreous hemorrhage
- diabetes
- glaucoma
- concurrent retinovascular disease
- previous ocular inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: TearsArtificial tears for 3 days preoperatively | Other | Placebo |
| DicloftilAlso: Diclofenac Na 0.1% Oph SolnDosing of drug 3 days prior to surgery | Drug | Dicloftil |
| NevanacAlso: Nepafenac 0.3% Ophthalmic SuspensionDosing of drug 3 days prior to surgery | Drug | Nevanac |
| IndomAlso: Indomethacin 5 MG/ML Ophthalmic SuspensionDosing of drug 3 days prior to surgery | Drug | Indom |
| YelloxAlso: Bromfenac 0.09 % Ophthalmic SolutionDosing of drug 3 days prior to surgery | Drug | Yellox |
Primary outcome
Vitreous NSAIDs and PGE2 levels
Time frame: 3 days after topical NSAID administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco R Pastore, MD principal investigator
Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dicloftil, Nevanac and Indom in people with Ocular Inflammation, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitreous NSAIDs and PGE2 levels (time frame: 3 days after topical NSAID administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.