Corneal InfiltratesPhase 2NCT00579020
A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
A Phase 2 study testing Moxifloxacin/dexamethasone phosphate ophthalmic solution, Moxifloxacin ophthalmic solution 0.5% and Dexamethasone phosphate solution, 0.1% in people with Corneal Infiltrates, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Corneal Infiltrates
- What is being tested?
- Moxifloxacin/dexamethasone phosphate ophthalmic solution, Moxifloxacin ophthalmic solution 0.5% and Dexamethasone phosphate solution, 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Age related.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center at 1-888-451-3937
Fort Worth, Texas, 76134
About this study
Official title: An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.
- Conditions
- Corneal Infiltrates
- Being tested
- Moxifloxacin/dexamethasone phosphate ophthalmic solution, Moxifloxacin ophthalmic solution 0.5%, Dexamethasone phosphate solution, 0.1%
- Keywords
- cornea, inflammation, blepharitis, lid infection
- Medical subject headings
- Corneal Diseases, Inflammation, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin/dexamethasone phosphate ophthalmic solutionDrug
Also called Moxidex
Moxifloxacin ophthalmic solution 0.5%Drug
Dexamethasone phosphate solution, 0.1%Drug
| Study group | Role | What they receive |
|---|---|---|
| Moxidex | Experimental | Moxifloxacin/dexamethasone phosphate ophthalmic solution, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days Receives: Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution |
| Moxifloxacin | Active comparator | Moxifloxacin ophthalmic solution 0.5%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days Receives: Drug: Moxifloxacin ophthalmic solution 0.5% |
| Dexamethasone | Active comparator | Dexamethasone phosphate solution, 0.1%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days Receives: Drug: Dexamethasone phosphate solution, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
Measured: Day 10
Secondary outcomes (1)
Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal InfiltratesStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579020
- Sponsor's protocol ID
- C-05-04
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2007
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
- ClinicalTrials.gov ID
- NCT00579020
- Acronym / sponsor ID
- C-05-04
- Conditions
- Corneal Infiltrates
- Keywords
- cornea, inflammation, blepharitis, lid infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
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 the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxidex | Experimental | Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solutionMoxifloxacin/dexamethasone phosphate ophthalmic solution, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin ophthalmic solution 0.5%Moxifloxacin ophthalmic solution 0.5%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days |
| Dexamethasone | Active comparator | Drug: Dexamethasone phosphate solution, 0.1%Dexamethasone phosphate solution, 0.1%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Age related.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Moxifloxacin/dexamethasone phosphate ophthalmic solutionAlso: Moxidex | Drug | Moxidex |
| Moxifloxacin ophthalmic solution 0.5% | Drug | Moxifloxacin |
| Dexamethasone phosphate solution, 0.1% | Drug | Dexamethasone |
Primary outcome
Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
Time frame: Day 10
1 secondary outcome
Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)
Time frame: Day 10
Results and safety
The study was stopped early (reason given: Management decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxifloxacin/dexamethasone phosphate ophthalmic solution, Moxifloxacin ophthalmic solution 0.5% and Dexamethasone phosphate solution, 0.1% in people with Corneal Infiltrates, run by Alcon Research 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Dec 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Management decision). Results are not available in the source record.
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?
Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10) (time frame: Day 10). 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 5 Dec 2012.