Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
|
| Gatifloxacin | Experimental | Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin | Drug | 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Epithelial Healing Time | patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days) | 3 to 4 days after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| KRAIG S. BOWER, MD | Walter Reed Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin/Gatifloxacin Treatment | Both eyes were treated. Each participant was randomly assigned to either: Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gatifloxacin | Drug | 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
35 out of 40 participants had complete data for analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin/Gatifloxacin Treatment | Both eyes were treated. Each participant was randomly assigned to either: Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Epithelial Healing Time | patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days) | Posted | Median | Full Range | days to complete epithelial healing | 3 to 4 days after surgery | eyes | Participants |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events Not Collected | Adverse Events Not Collected | 0 | 0 | 0 | 0 |
Not provided
Not provided
All materials that reflects the WRAMC affiliation must be approved and properly cleared before the material is submitted for public dissemination and publication. All publications whereby WRAMC is cited in the bylines will state on the cover page the following sample disclaimer: "The views expressed in this [article, book chapter, speech, presentation, etc.] are those of the author(s) and do not reflect the official policy of the Department of Army, Department of Defense, or U.S. Government."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | U.S. Army Warfighter Refractive Surgery Research Center | 571-231-1600 | rose.sia@us.army.mil |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided