Epithelium, CornealNCT00414011
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)
A study testing Moxifloxacin and Gatifloxacin in people with Epithelium, Corneal, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epithelium, Corneal
- What is being tested?
- Moxifloxacin and Gatifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Feb 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
Who cannot join
- Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Anterior basement membrane dystrophy.
- History of recurrent epithelial erosion.
- Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes)
- Other corneal epithelial disorder or healing abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
- Conditions
- Epithelium, Corneal
- Being tested
- Moxifloxacin, Gatifloxacin
- Keywords
- Removal of corneal epithelium followed by excimer laser treatment during prk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
GatifloxacinDrug
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery Receives: Drug: Moxifloxacin |
| Gatifloxacin | Experimental | Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery Receives: Drug: Gatifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelial Healing Time
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Measured: 3 to 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelium, CornealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- KRAIG S. BOWER, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414011
- Sponsor's protocol ID
- WRAMC WU # 04-2335-99e
- Status last verified
- Jun 2013
- First submitted
- 19 Dec 2006
- Last updated
- 17 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00414011
- Acronym / sponsor ID
- WRAMC WU # 04-2335-99e
- Conditions
- Epithelium, Corneal
- Keywords
- Removal of corneal epithelium followed by excimer laser treatment during prk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 20 Dec 2006 (estimated)
- Results
- Posted 26 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: MoxifloxacinMoxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
| Gatifloxacin | Experimental | Drug: GatifloxacinGatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
Key exclusion criteria (6 listed)
- Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Anterior basement membrane dystrophy.
- History of recurrent epithelial erosion.
- Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery | Drug | Moxifloxacin |
| Gatifloxacin1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery | Drug | Gatifloxacin |
Primary outcome
Corneal Epithelial Healing Time
Time frame: 3 to 4 days after surgery
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epithelium, Corneal
RecruitingPhase 4
Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus
Keratoconus
Active, not recruiting
Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)
Corneal Astigmatism
RecruitingObservational study
Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma
Glaucoma, Ocular Hypertension
Recruiting
Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency
Not yet recruitingPhase 4
Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Corneal Epithelial Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KRAIG S. BOWER, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxifloxacin and Gatifloxacin in people with Epithelium, Corneal, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Epithelial Healing Time (time frame: 3 to 4 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.