NCT00992355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

October 9, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 8, 2009

Last Update Submit

October 8, 2009

Conditions

Cataract

Keywords

CataractPhacoemulsificationTreatment duration

Study Arms (2)

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

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

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phacoemulsification (due to cataract)
  • Uneventful phacoemulsification surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Veroia General Hospital

Véroia, 59100, Greece

Location

MeSH Terms

Conditions

Cataract

Interventions

TobramycinDexamethasone

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

October 9, 2009

Record last verified: 2009-10

Locations

GR(1)