Bilateral CataractPhase 3TBONCT02734459
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
A Phase 3 study testing cataract surgery in people with Bilateral Cataract, run by Semler Research Center Pvt. Ltd..
Trial summary
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Cataract
- What is being tested?
- cataract surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Mar 2016
- 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
- Be male or female 18 years of age and above
- Presence of visually significant cataracts in both eyes
- Have a chief complaint consistent with visually significant cataracts
- Be able to communicate effectively with the study personnel and be able to understand and follow directions
- Be medically fit with clinically acceptable laboratory profiles and ECG
- Be willing to carry out the required pre op directions and post op care and be able to make the scheduled appointment
- Have given the written informed consent for participation in the study
- In addition, female patients of child bearing potential age must have a negative urine pregnancy test
Who cannot join
- Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening
- Presence or history of recent viral corneal disorder or active corneal condition which is contraindicated.
- Presence or history of uveitis or uveitis
- Presence of retinal disorders
- Ocular trauma within three months of the trial
- Patients who had received topical and or systemic/ oral steroids
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- Uncontrolled diabetes
- History of any allergies
- Known hypersensitivity or allergy to TobraDex® in combination or its components
- Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant as determined by the investigator(s)
- Clinically significant illness during 3 weeks prior to Visit 1 (as determined by the investigators)
- Presence of a clinically significant systemic disorder
About this study
Official title: A Multi Center, Open Label, Randomized, Two- Treatment, Single Dose, Crossover, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Ointment) To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin 0.3% And Dexamethasone 0.1% W/W In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.
- Conditions
- Bilateral Cataract
- Being tested
- cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDrug
the patient will be dosed with the study drug into the "V" pocket is formed between the eye ball and the lower eyelid during cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| tobramycin and dexamethasone ophthalmic test ointment | Experimental | The test drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in one eye before the cataract surgery. Receives: Drug: cataract surgery |
| TobraDex® ointment | Active comparator | The reference drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in another eye before the cataract surgery. Receives: Drug: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs.
A series of aqueous humor samples will be collected from each eye of each patient.
Measured: 30 min - 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral CataractStudies 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semler Research Center Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genzum Life Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734459
- Sponsor's protocol ID
- S-10-084
- Acronym
- TBO
- Status last verified
- Apr 2016
- First submitted
- 24 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Open Label, Randomized, Two- Treatment, Single Dose, Crossover, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Ointment) To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin 0.3% And Dexamethasone 0.1% W/W In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
- ClinicalTrials.gov ID
- NCT02734459
- Acronym / sponsor ID
- TBO / S-10-084
- Conditions
- Bilateral Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Semler Research Center Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Genzum Life Sciences
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Apr 2016 (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.
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tobramycin and dexamethasone ophthalmic test ointment | Experimental | Drug: cataract surgeryThe test drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in one eye before the cataract surgery. |
| TobraDex® ointment | Active comparator | Drug: cataract surgeryThe reference drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in another eye before the cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be male or female 18 years of age and above
- Presence of visually significant cataracts in both eyes
- Have a chief complaint consistent with visually significant cataracts
- Be able to communicate effectively with the study personnel and be able to understand and follow directions
- Be medically fit with clinically acceptable laboratory profiles and ECG
Key exclusion criteria (12 listed)
- Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening
- Presence or history of recent viral corneal disorder or active corneal condition which is contraindicated.
- Presence or history of uveitis or uveitis
- Presence of retinal disorders
- Ocular trauma within three months of the trial
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 |
|---|---|---|
| cataract surgerythe patient will be dosed with the study drug into the "V" pocket is formed between the eye ball and the lower eyelid during cataract surgery. | Drug | TobraDex® ointment, tobramycin and dexamethasone ophthalmic test ointment |
Primary outcome
Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs.
Time frame: 30 min - 8 hours
A series of aqueous humor samples will be collected from each eye of each patient.
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 12 Apr 2016.
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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 cataract surgery in people with Bilateral Cataract, run by Semler Research Center Pvt. Ltd..
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 8 inclusion and 12 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 12 Apr 2016. 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 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 at different time points after administration of a single dose of each of the two drugs. (time frame: 30 min - 8 hours). 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 12 Apr 2016.