An interventional study of Moxifloxacin and Gatifloxacin in Epithelium, Corneal, sponsored by Walter Reed Army Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-17.
Sponsored by Walter Reed Army Medical Center · Not applicable, Interventional, and Treatment
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.
Walter Reed Army Medical Center is the lead sponsor of 45 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Drug: Moxifloxacin
Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Drug: Gatifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Corneal Epithelial Healing Time
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Time frame: 3 to 4 days after surgery
| Milestone | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| Started | 40 |
| Completed | 35 |
| Not completed | 5 |
| Withdrew: Physician decision | 3 |
| Withdrew: Withdrawal by subject | 2 |
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
| days to complete epithelial healing | Moxifloxacin | Gatifloxacin |
|---|---|---|
| Corneal Epithelial Healing Time | 4 ± 1 | 4 ± 1.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events Not Collected | — | — | — |
35 out of 40 participants had complete data for analysis.
| Age, Categorical(Participants) | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 35 |
| >=65 years | 0 |
| Age Continuous(years) | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| Mean | 33.7 ± 7 |
| Sex: Female, Male(Participants) | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| Female | 16 |
| Male | 19 |
| Region of Enrollment(participants) | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| United States | 35 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Walter Reed Army Medical Center