Dry EyePhase 1NCT00695435
Tobramycin Tear Concentrations
A Phase 1 study testing TOBRADEX Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension and TOBREX Ophthalmic Solution in people with Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- TOBRADEX Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension and TOBREX Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2008
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Visual Acuity (VA) of 0.6 logMAR or better
- Tear meniscus height of ≥ 0.3mm at Visit 1.
- No concomitant topical ocular medications, including artificial tears, during the study period
Who cannot join
- ocular hypertension, iritis or uveitis, glaucoma
- ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
- epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
- lacrimal duct obstruction, dry eye, ocular allergies.
- contact lens within 7 days of Visit 1.
- ocular medications within 14 days of Visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers
To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
- Conditions
- Dry Eye
- Being tested
- TOBRADEX Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension, TOBREX Ophthalmic Solution
- Keywords
- normal volunteers, anti-infective, tobramycin
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOBRADEX Ophthalmic SuspensionDrug
TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionDrug
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
TOBREX Ophthalmic SolutionDrug
TOBREX Ophthalmic Solution 1 drop each eye at baseline
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Experimental | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Receives: Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
| TOBREX® Ophthalmic Solution | Active comparator | TOBREX® Ophthalmic Solution Receives: Drug: TOBREX Ophthalmic Solution |
| TOBRADEX® Ophthalmic Suspension | Active comparator | TOBRADEX® Ophthalmic Suspension Receives: Drug: TOBRADEX Ophthalmic Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobramycin Tear Concentration Cmax (Maximum Concentration)
Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.
Measured: 2, 4, 6, 12, and 18 minutes
Secondary outcomes (1)
Tobramycin Tear Concentration Area Under the Curve (AUC)
Trapezoidal AUC was calculated from 2 to 18 minutes.
Measured: 2 to 18 minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2008
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 Dry EyeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695435
- Sponsor's protocol ID
- C-08-33
- Status last verified
- Feb 2010
- First submitted
- 9 Jun 2008
- Last updated
- 2 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers
- ClinicalTrials.gov ID
- NCT00695435
- Acronym / sponsor ID
- C-08-33
- Conditions
- Dry Eye
- Keywords
- normal volunteers, anti-infective, tobramycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2008 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 5 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Experimental | Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
| TOBREX® Ophthalmic Solution | Active comparator | Drug: TOBREX Ophthalmic SolutionTOBREX® Ophthalmic Solution |
| TOBRADEX® Ophthalmic Suspension | Active comparator | Drug: TOBRADEX Ophthalmic SuspensionTOBRADEX® Ophthalmic Suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Visual Acuity (VA) of 0.6 logMAR or better
- Tear meniscus height of ≥ 0.3mm at Visit 1.
- No concomitant topical ocular medications, including artificial tears, during the study period
Key exclusion criteria (6 listed)
- ocular hypertension, iritis or uveitis, glaucoma
- ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
- epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
- lacrimal duct obstruction, dry eye, ocular allergies.
- contact lens within 7 days of Visit 1.
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 |
|---|---|---|
| TOBRADEX Ophthalmic SuspensionTOBRADEX Ophthalmic Suspension 1 drop each eye at baseline | Drug | TOBRADEX® Ophthalmic Suspension |
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline | Drug | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
| TOBREX Ophthalmic SolutionTOBREX Ophthalmic Solution 1 drop each eye at baseline | Drug | TOBREX® Ophthalmic Solution |
Primary outcome
Tobramycin Tear Concentration Cmax (Maximum Concentration)
Time frame: 2, 4, 6, 12, and 18 minutes
Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.
1 secondary outcome
Tobramycin Tear Concentration Area Under the Curve (AUC)
Time frame: 2 to 18 minutes post administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1 study testing TOBRADEX Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension and TOBREX Ophthalmic Solution in people with Dry Eye, 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 3 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 2 Mar 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2010). 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?
Tobramycin Tear Concentration Cmax (Maximum Concentration) (time frame: 2, 4, 6, 12, and 18 minutes). 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 2 Mar 2010.