A Phase 3 interventional study of Ketorolac 0.5% eyedrops and Indomethacin 0.5% eyedrops in Vitreous Inflammation, sponsored by Università degli Studi di Brescia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.
Sponsored by Università degli Studi di Brescia · Phase 3, Interventional, and Treatment
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).
Università degli Studi di Brescia is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
No NSAIDs were administered prior to surgery
Ketorolac 0.5% eyedrops were administered prior to surgery
Drug: Ketorolac 0.5% eyedrops
Indomethacin 0.5% eyedrops were administered prior to surgery
Drug: Indomethacin 0.5% eyedrops
Nepafenac 0.1% eyedrops were administered prior to surgery
Drug: Nepafenac 0.1% eyedrops
Bromfenac 0.09% eyedrops were administered prior to surgery
Drug: Bromfenac 0.09% eyedrops
Prostaglandin E2 levels in the vitreous (pg/mL)
Time frame: 7 days after NSAID TID administration, following vitrectomy
NSAIDs concentration (ng/mL) into the vitreous
Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system.
Time frame: 7 days after NSAID TID administration, following vitrectomy
Adverse events
Time frame: 7 days after NSAID TID administration, following vitrectomy
No study locations are listed for this record.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketorolac · Indomethacin · Bromfenac · Nepafenac
Università degli Studi di Brescia