Trial Outcomes & Findings for Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99) (NCT NCT00414011)
NCT ID: NCT00414011
Last Updated: 2013-07-17
Results Overview
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 to 4 days after surgery
Results posted on
2013-07-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)
Baseline characteristics by cohort
| Measure |
Moxifloxacin/Gatifloxacin Treatment
n=35 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age Continuous
|
33.7 years
STANDARD_DEVIATION 7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 3 to 4 days after surgerypatients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Outcome measures
| Measure |
Moxifloxacin
n=35 eyes
Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
|
Gatifloxacin
n=35 eyes
Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
|
|---|---|---|
|
Corneal Epithelial Healing Time
|
4 days to complete epithelial healing
Full Range 1 • Interval 3.0 to 7.0
|
4 days to complete epithelial healing
Full Range 1.4 • Interval 3.0 to 9.0
|
Adverse Events
Adverse Events Not Collected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
U.S. Army Warfighter Refractive Surgery Research Center
Phone: 571-231-1600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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."
- Publication restrictions are in place
Restriction type: OTHER