CataractsPhase 3NCT01515826
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
A Phase 3 study testing Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) and Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) in people with Cataracts, run by Alcon Research.
Trial summary
The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) and Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
- Able to understand and sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Glaucoma or ocular hypertension.
- Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
- Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
- Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
- Planned use of contact lenses in the study eye during the study period.
- Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
- History of clinically significant trauma to the study eye within the past 12 months.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
- Conditions
- Cataracts
- Being tested
- Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel), Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
- Keywords
- Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)Drug
Also called FID 119149, VIGADEXA Gel
One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)Drug
Also called VIGADEXA Solution
One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
| Study group | Role | What they receive |
|---|---|---|
| VIGADEXA Gel | Experimental | VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. Receives: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) |
| VIGADEXA Solution | Active comparator | VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. Receives: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
As assessed by the investigator during slit-lamp examination.
Measured: Day 15 post-operative
Percentage of patients with no clinically evidenced bacterial infection
As assessed by the investigator during slit-lamp examination.
Measured: Day 15 post-operative
Secondary outcomes (3)
Cells in the anterior chamber (study eye)
As assessed by the investigator during slit-lamp examination.
Measured: Day 15 post-operative
Ocular pain (study eye)
As assessed by the investigator during patient interview.
Measured: Day 15 post-operative
Inflammatory reaction (study eye)
As assessed by the investigator during slit-lamp examination.
Measured: Day 15 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startMar 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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 CataractsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 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
- NCT01515826
- Sponsor's protocol ID
- C-10-013
- Status last verified
- Mar 2014
- First submitted
- 19 Jan 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT01515826
- Acronym / sponsor ID
- C-10-013
- Conditions
- Cataracts
- Keywords
- Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 24 Jan 2012 (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 this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIGADEXA Gel | Experimental | Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. |
| VIGADEXA Solution | Active comparator | Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
- Able to understand and sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Glaucoma or ocular hypertension.
- Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
- Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
- Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
- Planned use of contact lenses in the study eye during the study period.
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 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)Also: FID 119149, VIGADEXA GelOne ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery. | Drug | VIGADEXA Gel |
| Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)Also: VIGADEXA SolutionOne drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery. | Drug | VIGADEXA Solution |
Primary outcome
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
Time frame: Day 15 post-operative
As assessed by the investigator during slit-lamp examination.
Percentage of patients with no clinically evidenced bacterial infection
Time frame: Day 15 post-operative
As assessed by the investigator during slit-lamp examination.
3 secondary outcomes
Cells in the anterior chamber (study eye)
Time frame: Day 15 post-operative
Ocular pain (study eye)
Time frame: Day 15 post-operative
Inflammatory reaction (study eye)
Time frame: Day 15 post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) and Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) in people with Cataracts, run by Alcon Research.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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 a score of 0 (<5 cells) for cells in the anterior chamber (time frame: Day 15 post-operative). The study lists 2 primary outcomes in all. 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 26 Mar 2014.