Trial Outcomes & Findings for Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL. (NCT NCT05372315)
NCT ID: NCT05372315
Last Updated: 2023-08-23
Results Overview
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
at Day 8
Results posted on
2023-08-23
Participant Flow
Single medical clinic open enrollment from June-October 2022.
Participant milestones
| Measure |
Lower Punctum Insertion (Group 1)
Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg).
|
Upper Punctum Insertion (Group 2)
Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lower Punctum Insertion (Group 1)
Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg).
|
Upper Punctum Insertion (Group 2)
Participants undergoing cataract surgery with IOL implant with or with out Istent, Hydrus, or Goniotomy who will receive dexamethasone ophthalmic insert 0.4mg).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Baseline characteristics by cohort
| Measure |
Lower Punctum Insertion (Group 1)
n=39 Participants
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
|
Upper Punctum Insertion (Group 2)
n=40 Participants
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
68.4 years
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Surgical Procedure
Cataract Surgery Only
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Surgical Procedure
Cataract-MIGS
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cataract Type
Nuclear
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Cataract Type
Cortical
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at Day 8Population: Participants with complete absence of ocular pain at day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Outcome measures
| Measure |
Lower Punctum Insertion (Group 1)
n=39 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
Lower Punctum Insertion (Group 2)
n=40 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
|---|---|---|
|
Participants With Complete Absence of Ocular Pain at Day 8
No Post Op Pain Reported
|
39 Participants
|
39 Participants
|
|
Participants With Complete Absence of Ocular Pain at Day 8
Post Op Pain Reported
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: at Day 14Population: Lower and Upper Punctum Insertion
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
Outcome measures
| Measure |
Lower Punctum Insertion (Group 1)
n=39 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
Lower Punctum Insertion (Group 2)
n=40 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
|---|---|---|
|
Participants With Zero Cells on Day 14
Patients with Cell
|
1 Participants
|
3 Participants
|
|
Participants With Zero Cells on Day 14
Patients with Zero Cell
|
38 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Easy, Moderate, Difficult.
Rated as Easy, Moderate, Difficult
Outcome measures
| Measure |
Lower Punctum Insertion (Group 1)
n=39 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
Lower Punctum Insertion (Group 2)
n=40 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
|---|---|---|
|
Ease of Insertion
Easy
|
36 Participants
|
36 Participants
|
|
Ease of Insertion
Moderate
|
2 Participants
|
4 Participants
|
|
Ease of Insertion
Difficult
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Attempts at Upper and Lower insertion
Number of attempts to insert the dexamethasone insert in the upper or lower punctum.
Outcome measures
| Measure |
Lower Punctum Insertion (Group 1)
n=39 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
Lower Punctum Insertion (Group 2)
n=40 Participants
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
|---|---|---|
|
Attempts to Achieve Successful Insertion
One Attempt
|
38 Participants
|
35 Participants
|
|
Attempts to Achieve Successful Insertion
Two Attempts
|
1 Participants
|
5 Participants
|
Adverse Events
Lower Punctum Insertion (Group 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Upper Punctum Insertion (Group 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lower Punctum Insertion (Group 1)
n=39 participants at risk
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
Upper Punctum Insertion (Group 2)
n=40 participants at risk
Dexamethasone ophthalmic insert, 0.4mg intracanalicular insert in the lower punctum on the day of surgery in the OR.
|
|---|---|---|
|
Eye disorders
Increased IOP
|
0.00%
0/39 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
2.5%
1/40 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
|
Eye disorders
CME
|
2.6%
1/39 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
2.5%
1/40 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/39 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
2.5%
1/40 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
|
Eye disorders
Anterior Chamber Inflammation
|
2.6%
1/39 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
2.5%
1/40 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
|
Eye disorders
Corneal Edema
|
2.6%
1/39 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
0.00%
0/40 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
|
Eye disorders
Insert Fell Out
|
2.6%
1/39 • Number of events 1 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
0.00%
0/40 • 30 days
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom or disease, temporally associated with the participants' participation in the research, whether or not considered related to the participant's participation on the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place