Cataract
Conditions
Brief summary
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.
Interventions
DRUGDexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
DRUGPlacebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned single cataract extraction with lens implant * Best-corrected visual acuity of 20/200 or better in the opposite eye
Exclusion criteria
* Glaucoma or history of intraocular hypertension in the study eye * History of chronic ocular allergy in the last year requiring treatment * Scheduled for cataract surgery in the non-study eye during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clearance of Anterior Chamber Inflammation | Up to Day 71 | The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Levels of Dexamethasone | Day 2, Day 7, Day 14 | Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood. |
Countries
United States
Participant flow
Recruitment details
This study was terminated due to corporate decision and enrollment was not completed.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Drug Delivery System Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | 6 |
| Placebo Drug Delivery System Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | 2 |
| Total | 8 |
Baseline characteristics
| Characteristic | Dexamethasone Drug Delivery System | Placebo Drug Delivery System | Total |
|---|---|---|---|
| Age, Customized <45 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Customized Between 45 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 2 / 2 |
| serious Total, serious adverse events | 2 / 6 | 0 / 2 |
Outcome results
Primary
Number of Patients With Clearance of Anterior Chamber Inflammation
The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).
Time frame: Up to Day 71
Population: Safety: all patients who received study treatment at randomization/surgery (day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone Drug Delivery System | Number of Patients With Clearance of Anterior Chamber Inflammation | 4 Patients |
| Placebo Drug Delivery System | Number of Patients With Clearance of Anterior Chamber Inflammation | 1 Patients |
Secondary
Plasma Levels of Dexamethasone
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Time frame: Day 2, Day 7, Day 14
Population: Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Drug Delivery System | Plasma Levels of Dexamethasone | Day 2 | 0.101 Nanograms/Milliliter (ng/mL) | Standard Deviation 0.038 |
| Dexamethasone Drug Delivery System | Plasma Levels of Dexamethasone | Day 7 | 0 Nanograms/Milliliter (ng/mL) | — |
| Dexamethasone Drug Delivery System | Plasma Levels of Dexamethasone | Day 14 | 0 Nanograms/Milliliter (ng/mL) | — |