Trial Outcomes & Findings for A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery (NCT NCT01605942)
NCT ID: NCT01605942
Last Updated: 2015-07-01
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to Day 71
Results posted on
2015-07-01
Participant Flow
This study was terminated due to corporate decision and enrollment was not completed.
Participant milestones
| Measure |
Dexamethasone 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
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Baseline characteristics by cohort
| Measure |
Dexamethasone Drug Delivery System
n=6 Participants
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Placebo Drug Delivery System
n=2 Participants
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 45 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 71Population: Safety: all patients who received study treatment at randomization/surgery (day 1)
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).
Outcome measures
| Measure |
Dexamethasone Drug Delivery System
n=6 Participants
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Placebo Drug Delivery System
n=2 Participants
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
|
4 Patients
|
1 Patients
|
SECONDARY outcome
Timeframe: Day 2, Day 7, Day 14Population: Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Outcome measures
| Measure |
Dexamethasone Drug Delivery System
n=6 Participants
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Placebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
|---|---|---|
|
Plasma Levels of Dexamethasone
Day 2
|
0.101 Nanograms/Milliliter (ng/mL)
Standard Deviation 0.038
|
—
|
|
Plasma Levels of Dexamethasone
Day 7
|
0 Nanograms/Milliliter (ng/mL)
Standard Deviation NA
Below the lower limit of quantitation
|
—
|
|
Plasma Levels of Dexamethasone
Day 14
|
0 Nanograms/Milliliter (ng/mL)
Standard Deviation NA
Below the lower limit of quantitation
|
—
|
Adverse Events
Dexamethasone Drug Delivery System
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Drug Delivery System
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone Drug Delivery System
n=6 participants at risk
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Placebo Drug Delivery System
n=2 participants at risk
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
|---|---|---|
|
Eye disorders
Corneal Oedema
|
33.3%
2/6
|
0.00%
0/2
|
|
Eye disorders
Retinal Tear
|
16.7%
1/6
|
0.00%
0/2
|
Other adverse events
| Measure |
Dexamethasone Drug Delivery System
n=6 participants at risk
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
Placebo Drug Delivery System
n=2 participants at risk
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
|
|---|---|---|
|
Eye disorders
Anterior Chamber Cell
|
100.0%
6/6
|
100.0%
2/2
|
|
Eye disorders
Anterior Chamber Flare
|
100.0%
6/6
|
100.0%
2/2
|
|
Eye disorders
Corneal Oedema
|
83.3%
5/6
|
100.0%
2/2
|
|
Eye disorders
Conjunctival Oedema
|
50.0%
3/6
|
100.0%
2/2
|
|
Eye disorders
Corneal Deposits
|
50.0%
3/6
|
0.00%
0/2
|
|
Investigations
Intraocular Pressure Increased
|
50.0%
3/6
|
0.00%
0/2
|
|
Eye disorders
Iris Adhesions
|
50.0%
3/6
|
0.00%
0/2
|
|
Eye disorders
Punctate Keratitis
|
50.0%
3/6
|
0.00%
0/2
|
|
Eye disorders
Conjunctival Hyperaemia
|
33.3%
2/6
|
100.0%
2/2
|
|
Eye disorders
Visual Acuity Reduced
|
33.3%
2/6
|
50.0%
1/2
|
|
Eye disorders
Eye Pain
|
33.3%
2/6
|
0.00%
0/2
|
|
Eye disorders
Eye Pruritus
|
33.3%
2/6
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
33.3%
2/6
|
0.00%
0/2
|
|
Eye disorders
Photophobia
|
33.3%
2/6
|
0.00%
0/2
|
|
General disorders
Facial Pain
|
16.7%
1/6
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Conjunctival Haemorrhage
|
16.7%
1/6
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Glare
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Halo Vision
|
16.7%
1/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
16.7%
1/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Retinal Degeneration
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Retinal Tear
|
16.7%
1/6
|
0.00%
0/2
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Vitreous Detachment
|
16.7%
1/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6
|
0.00%
0/2
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/6
|
100.0%
2/2
|
|
Eye disorders
Eye Irritation
|
0.00%
0/6
|
50.0%
1/2
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/6
|
50.0%
1/2
|
|
Eye disorders
Photopsia
|
0.00%
0/6
|
50.0%
1/2
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/6
|
50.0%
1/2
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/6
|
50.0%
1/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER