A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01605942
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexamethasone Drug Delivery System; Drug: Placebo Drug Delivery System	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Drug Delivery System Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.	Drug: Dexamethasone Drug Delivery System; Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Comparator: Placebo 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; Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Newport Beach	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01605942
• Other Study ID Numbers: 206207-027
• First Posted: May 25, 2012
• Last Update Posted: Jul 1, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Cataract; Dexamethasone

Study Results

Participant Flow

Recruitment Details	This study was terminated due to corporate decision and enrollment was not completed.

Arm/Group Title	Dexamethasone Drug Delivery System	Placebo Drug Delivery System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	6	2
COMPLETED	6	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dexamethasone Drug Delivery System	Placebo Drug Delivery System	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	6	2	8
Age, Customized (Number) [Number]
<45 years	0 0%	0 0%	0 0%
Between 45 and 65 years	1 16.7%	0 0%	1 12.5%
>65 years	5 83.3%	2 100%	7 87.5%
Sex: Female, Male (Count of Participants)
Female	3 50%	0 0%	3 37.5%
Male	3 50%	2 100%	5 62.5%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Clearance of Anterior Chamber Inflammation
Description	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

Outcome Measure Data

Analysis Population Description

Safety: all patients who received study treatment at randomization/surgery (day 1)

Arm/Group Title	Dexamethasone Drug Delivery System	Placebo Drug Delivery System
Arm/Group Description	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.
Measure Participants	6	2
Number [Patients]	4	1

2. Secondary Outcome

Title	Plasma Levels of Dexamethasone
Description	Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Time Frame	Day 2, Day 7, Day 14

Outcome Measure Data

Analysis Population Description

Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.

Arm/Group Title	Dexamethasone Drug Delivery System
Arm/Group Description	Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Measure Participants	6
Day 2	0.101 (0.038)
Day 7	0 (NA)
Day 14	0 (NA)

Adverse Events

Arm/Group Title	Dexamethasone Drug Delivery System		Placebo Drug Delivery System
Arm/Group Description	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.
All Cause Mortality
	Dexamethasone Drug Delivery System		Placebo Drug Delivery System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexamethasone Drug Delivery System		Placebo Drug Delivery System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)		0/2 (0%)
Eye disorders
Corneal Oedema	2/6 (33.3%)		0/2 (0%)
Retinal Tear	1/6 (16.7%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone Drug Delivery System		Placebo Drug Delivery System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100%)		2/2 (100%)
Eye disorders
Anterior Chamber Cell	6/6 (100%)		2/2 (100%)
Anterior Chamber Flare	6/6 (100%)		2/2 (100%)
Corneal Oedema	5/6 (83.3%)		2/2 (100%)
Conjunctival Oedema	3/6 (50%)		2/2 (100%)
Corneal Deposits	3/6 (50%)		0/2 (0%)
Iris Adhesions	3/6 (50%)		0/2 (0%)
Punctate Keratitis	3/6 (50%)		0/2 (0%)
Conjunctival Hyperaemia	2/6 (33.3%)		2/2 (100%)
Visual Acuity Reduced	2/6 (33.3%)		1/2 (50%)
Eye Pain	2/6 (33.3%)		0/2 (0%)
Eye Pruritus	2/6 (33.3%)		0/2 (0%)
Photophobia	2/6 (33.3%)		0/2 (0%)
Conjunctival Haemorrhage	1/6 (16.7%)		0/2 (0%)
Foreign Body Sensation in Eyes	1/6 (16.7%)		0/2 (0%)
Glare	1/6 (16.7%)		0/2 (0%)
Halo Vision	1/6 (16.7%)		0/2 (0%)
Retinal Degeneration	1/6 (16.7%)		0/2 (0%)
Retinal Tear	1/6 (16.7%)		0/2 (0%)
Vitreous Detachment	1/6 (16.7%)		0/2 (0%)
Eyelid Oedema	0/6 (0%)		2/2 (100%)
Eye Irritation	0/6 (0%)		1/2 (50%)
Lacrimation Increased	0/6 (0%)		1/2 (50%)
Photopsia	0/6 (0%)		1/2 (50%)
Posterior Capsule Opacification	0/6 (0%)		1/2 (50%)
Vitreous Floaters	0/6 (0%)		1/2 (50%)
Gastrointestinal disorders
Nausea	1/6 (16.7%)		0/2 (0%)
Vomiting	1/6 (16.7%)		0/2 (0%)
General disorders
Facial Pain	1/6 (16.7%)		1/2 (50%)
Infections and infestations
Upper Respiratory Tract Infection	1/6 (16.7%)		0/2 (0%)
Investigations
Intraocular Pressure Increased	3/6 (50%)		0/2 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/6 (16.7%)		0/2 (0%)
Musculoskeletal Pain	1/6 (16.7%)		0/2 (0%)
Nervous system disorders
Headache	2/6 (33.3%)		0/2 (0%)
Dizziness	1/6 (16.7%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.