Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00331084

Collaborator

(none)

132

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Condition or Disease	Intervention/Treatment	Phase
Inflammation Following Cataract Surgery	Drug: antibiotic/steroid combination Drug: moxifloxacin / dexamethasone	N/A

Detailed Description

Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: antibiotic steroid drops/single vial efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery	Drug: antibiotic/steroid combination 1 gtt, 4x/day, 15 days Other Names: moxifloxacin / dexamethasone
Active Comparator: antibiotic steroids drops efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery	Drug: moxifloxacin / dexamethasone 1 gtt 4x/day, 15 days

Arm

Intervention/Treatment

Experimental: antibiotic steroid drops/single vial

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Drug: antibiotic/steroid combination

1 gtt, 4x/day, 15 days

Other Names:

moxifloxacin / dexamethasone

Active Comparator: antibiotic steroids drops

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Drug: moxifloxacin / dexamethasone

1 gtt 4x/day, 15 days

Outcome Measures

Primary Outcome Measures

day 15 evaluation of anterior chamber [15 days pos-op]

Secondary Outcome Measures

day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score [15 days pos-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients having cataract surgery

Exclusion Criteria:

Uncontrolled glaucoma or intraocular hypertension;
Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
A history of chronic or recurrent ocular inflammatory disease;
Uncontrolled diabetes mellitus and diabetic retinopathy ;
Patients with sight in a single eye;
Iris atrophy in the eye to be operated;
Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
Known or suspected allergy or hypersensitivity to any component of study medication;
A history or any other evidence of severe systemic disease