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

Inflammation Following Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331084
• Other study ID #: BRA-05-01
• Status: Completed
• Phase: N/A
• First received: May 25, 2006
• Last updated: August 6, 2009
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Inflammation Following Cataract Surgery

Intervention

Drug:
• antibiotic/steroid combination
1 gtt, 4x/day, 15 days
• moxifloxacin / dexamethasone
1 gtt 4x/day, 15 days

Locations

Country	Name	City	State
Brazil	Dept of Opthalmology - Rua Botucatu 824	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	day 15 evaluation of anterior chamber		15 days pos-op	Yes
Secondary	day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score		15 days pos-op	Yes