Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

antibiotic/steroid combination

moxifloxacin/dexamethasone

About this trial

This is an interventional prevention trial for Post Lasik Surgery Inflammation focused on measuring prevention of post inflammation in LASIK surgery

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients having LASIK surgery; men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems 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

Sites / Locations

Dept. of Ophthalmology - Rua Botucatu 824

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

antibiotic steroid (single vial)

antibiotic / steroid (2 vials)

Arm Description

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

Outcomes

Primary Outcome Measures

day 15 evaluation of anterior chamber

Secondary Outcome Measures

day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score

Full Information

NCT ID

NCT00330824

First Posted

May 26, 2006

Last Updated

August 6, 2009

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00330824

Brief Title

Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

Official Title

Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

Detailed Description

antibiotic/steroid combination compared to individuals components 15 days of treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Lasik Surgery Inflammation

Keywords

prevention of post inflammation in LASIK surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

antibiotic steroid (single vial)

Arm Type

Experimental

Arm Description

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

Arm Title

antibiotic / steroid (2 vials)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

antibiotic/steroid combination

Other Intervention Name(s)

moxifloxacin/dexamethasone

Intervention Description

1gtt, 4x/d, 15 days

Intervention Type

Drug

Intervention Name(s)

moxifloxacin/dexamethasone

Other Intervention Name(s)

moxifloxacin / dexamethasone

Intervention Description

1gtt, 4x/days, 15 days

Primary Outcome Measure Information:

Title

day 15 evaluation of anterior chamber

Time Frame

15 days pos-op

Secondary Outcome Measure Information:

Title

day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score

Time Frame

15 days pos-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: patients having LASIK surgery; men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubens Belfort Jr, MD, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Ophthalmology - Rua Botucatu 824

City

São paulo

State/Province

SP

ZIP/Postal Code

04023-062

Country

Brazil

Post Lasik Surgery Inflammation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial