Trial Outcomes & Findings for Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL (NCT NCT01602068)
NCT ID: NCT01602068
Last Updated: 2019-01-29
Results Overview
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
At Day 7 (plus or minus two days) following the study treatment
Results posted on
2019-01-29
Participant Flow
Male or female patients at least 12 years of age and undergoing unilateral cataract surgery with implantation of a posterior chamber IOL could be screened
1:1 randomization
Participant milestones
| Measure |
Dexamethasone Phosphate Ophthalmic
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
100 mM Sodium Citrate Buffer
Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
Baseline characteristics by cohort
| Measure |
Dexamethasone Phosphate Ophthalmic
n=23 Participants
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
100 mM Sodium Citrate Buffer
n=22 Participants
Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
65 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Day 7 (plus or minus two days) following the study treatmentPopulation: This was an exploratory study and therefore a number of efficacy and safety parameters were evaluated. In all measures there was no significant difference between the active and non-active arms.
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
Outcome measures
| Measure |
Dexamethasone Phosphate Ophthalmic
n=23 Participants
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
100 mM Sodium Citrate Buffer
n=22 Participants
Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
|---|---|---|
|
Percentage of Subjects With AC Cell Count of Zero on Day 7
|
3 Participants
|
2 Participants
|
Adverse Events
Dexamethasone Phosphate Ophthalmic
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
100 mM Sodium Citrate Buffer
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone Phosphate Ophthalmic
n=23 participants at risk
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
100 mM Sodium Citrate Buffer
n=22 participants at risk
Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/23 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
4.5%
1/22 • Number of events 1 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
4.5%
1/22 • Number of events 1 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/23 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
4.5%
1/22 • Number of events 1 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
Other adverse events
| Measure |
Dexamethasone Phosphate Ophthalmic
n=23 participants at risk
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
100 mM Sodium Citrate Buffer
n=22 participants at risk
Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
|
|---|---|---|
|
Eye disorders
Ocular AE
|
91.3%
21/23 • Number of events 84 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
90.9%
20/22 • Number of events 70 • AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER