A Phase 1 interventional study of Dexamethasone Drug Delivery System and Placebo Drug Delivery System in Cataract, sponsored by Allergan. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-01.
Sponsored by Allergan · Phase 1, Interventional, and Treatment
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
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Exclusion Criteria:
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Dexamethasone Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Placebo Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
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
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
This study was terminated due to corporate decision and enrollment was not completed.
| Milestone | Dexamethasone Drug Delivery System | Placebo Drug Delivery System |
|---|---|---|
| Started | 6 | 2 |
| Completed | 6 | 2 |
| Not completed | 0 | 0 |
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).
| Patients | Dexamethasone Drug Delivery System | Placebo Drug Delivery System |
|---|---|---|
| Number of Patients With Clearance of Anterior Chamber Inflammation | 4 | 1 |
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
| Nanograms/Milliliter (ng/mL) | Dexamethasone Drug Delivery System |
|---|---|
| Day 2 | 0.101 ± 0.038 |
| Day 7 | 0 ± NA |
| Day 14 | 0 ± NA |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Drug Delivery System | — | 2/6 (33.3%) | 6/6 (100%) |
| Placebo Drug Delivery System | — | 0/2 (0%) | 2/2 (100%) |
| Event | Dexamethasone Drug Delivery System | Placebo Drug Delivery System |
|---|---|---|
| Corneal OedemaEye disorders | 2/6 | 0/2 |
| Retinal TearEye disorders | 1/6 | 0/2 |
| Event | Dexamethasone Drug Delivery System | Placebo Drug Delivery System |
|---|---|---|
| Anterior Chamber CellEye disorders | 6/6 | 2/2 |
| Anterior Chamber FlareEye disorders | 6/6 | 2/2 |
| Corneal OedemaEye disorders | 5/6 | 2/2 |
| Conjunctival OedemaEye disorders | 3/6 | 2/2 |
| Conjunctival HyperaemiaEye disorders | 2/6 | 2/2 |
| Eyelid OedemaEye disorders | 0/6 | 2/2 |
| Corneal DepositsEye disorders | 3/6 | 0/2 |
| Intraocular Pressure IncreasedInvestigations | 3/6 | 0/2 |
| Iris AdhesionsEye disorders | 3/6 | 0/2 |
| Punctate KeratitisEye disorders | 3/6 | 0/2 |
| Age, Customized(Participants) | Dexamethasone Drug Delivery System | Placebo Drug Delivery System | Total |
|---|---|---|---|
| <45 years | 0 | 0 | 0 |
| Between 45 and 65 years | 1 | 0 | 1 |
| >65 years | 5 | 2 | 7 |
| Sex: Female, Male(Participants) | Dexamethasone Drug Delivery System | Placebo Drug Delivery System | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 3 | 2 | 5 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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