CataractPhase 3NCT00362895
A Bioequivalence Study of Tobradex AF
A Phase 3 study testing Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension and Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension and Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 995 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2006
- 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 or older
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Under 18
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon for Trial Location(s)
Fort Worth, Texas, 76134
About this study
Official title: A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
- Conditions
- Cataract
- Being tested
- Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension, Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspensionDrug
One drop in the study eye, single dose
Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)Drug
Also called TOBRADEX®
One drop in the study eye, single dose
| Study group | Role | What they receive |
|---|---|---|
| Tobradex AF | Experimental | Not described Receives: Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension |
| TOBRADEX | Active comparator | Not described Receives: Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of dexamethasone in aqueous humor following a single topical ocular administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 995 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
- NCT00362895
- Sponsor's protocol ID
- C-05-23
- Status last verified
- Mar 2012
- First submitted
- 9 Aug 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
- ClinicalTrials.gov ID
- NCT00362895
- Acronym / sponsor ID
- C-05-23
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 995 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Aug 2006 (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 the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobradex AF | Experimental | Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension |
| TOBRADEX | Active comparator | Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (2 listed)
- Under 18
- 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 |
|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspensionOne drop in the study eye, single dose | Drug | Tobradex AF |
| Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)Also: TOBRADEX®One drop in the study eye, single dose | Drug | TOBRADEX |
Primary outcome
Concentration of dexamethasone in aqueous humor following a single topical ocular administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension and Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) in people with Cataract, 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: finished, as of the sponsor's last update on 5 Mar 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of dexamethasone in aqueous humor following a single topical ocular administration. 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 Mar 2012.