Trial Outcomes & Findings for DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 (NCT NCT04290676)
NCT ID: NCT04290676
Last Updated: 2021-05-26
Results Overview
Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam.
Recruitment status
COMPLETED
Target enrollment
527 participants
Primary outcome timeframe
Postoperative day 8
Results posted on
2021-05-26
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
DEXYCU (Dexamethasone Intraocular Suspension) 9%
All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
|
|---|---|
|
Overall Study
STARTED
|
527 641
|
|
Overall Study
COMPLETED
|
527 641
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
Baseline characteristics by cohort
| Measure |
DEXYCU (Dexamethasone Intraocular Suspension) 9%
n=641 eyes
All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
|
|---|---|
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Age, Continuous
|
71.5 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
308 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
327 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 8Population: eyes with a record at postoperative day 8
Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam.
Outcome measures
| Measure |
DEXYCU (Dexamethasone Intraocular Suspension) 9%
n=315 eyes
All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
|
|---|---|
|
Percentage of Eyes With Anterior Chamber Cell Grade 0
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65 percentage of eyes
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Adverse Events
DEXYCU (Dexamethasone Intraocular Suspension) 9%
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DEXYCU (Dexamethasone Intraocular Suspension) 9%
n=527 participants at risk
All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
|
|---|---|
|
Investigations
Intraocular pressure increased
|
1.1%
6/527 • Number of events 7 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Corneal edema
|
0.95%
5/527 • Number of events 6 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Iritis
|
0.76%
4/527 • Number of events 4 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Product Issues
DEXYCU on lens optic
|
0.19%
1/527 • Number of events 1 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Vision blurred
|
0.19%
1/527 • Number of events 1 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Retina peripheral hole
|
0.19%
1/527 • Number of events 1 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Hypotony maculopathy
|
0.19%
1/527 • Number of events 1 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
|
Eye disorders
Retained cortex in anterior chamber
|
0.19%
1/527 • Number of events 1 • This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee During the Study and for a period of ten (10) years after completion or early termination of the Multi-Center Retrospective Trial, without Sponsor's and/or its representative prior written consent, Institution and Investigator will not publish, disseminate or otherwise disclose, deliver or make available any Confidential Information to any third party other than Study Personnel or Sponsor's representative, and then only for the purpose of conducting the Study.
- Publication restrictions are in place
Restriction type: OTHER