Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone... | NCT00992355

Studies
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

NCT00992355

Sponsor

Veroia General Hospital

Status

Completed

Last Update Posted

Oct 9, 2009Estimated

Enrollment

97Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

Tobramycin 0.3% - Dexamethasone 0.1%
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Oct 8, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2009

Last Update Posted Date

Oct 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized controlled trial compares two regimens of topical therapy:

tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

corneal edema
conjunctival redness
anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tobramycin 0.3% - Dexamethasone 0.1%	Active Comparator		Drug: Tobramycin 0.3% - Dexamethasone 0.1%
Tobramycin-Dexamethasone plus Ketorolac tromethamine	Active Comparator		Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tobramycin 0.3% - Dexamethasone 0.1%	Drug		Tobramycin 0.3% - Dexamethasone 0.1%
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Phacoemulsification (due to cataract)
Uneventful phacoemulsification surgery

Exclusion Criteria:

Disruption of the anterior lens capsule
Age-related macular degeneration
Proliferative diabetic retinopathy
Glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Veroia General Hospital		Véroia		59100	Greece

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014031	Tobramycin
D003907	Dexamethasone

Ancestor Terms

ID	Term
D009328	Nebramycin
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241

Browse Leaves

Not provided

Browse Branches

Not provided