Eye InfectionsPhase 3NCT00198523
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
A Phase 3 study testing Prednisolone and Tobramycin and Prednisolone in people with Eye Infections and Postoperative Complications, run by Bausch & Lomb Incorporated at 6 sites in United States.
Trial summary
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Infections, Postoperative Complications
- What is being tested?
- Prednisolone and Tobramycin and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2005to Oct 2005
- 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
- Bilateral cataract surgery
- Avoid disallowed medications throughout study
Who cannot join
- Contraindications to the use of the test agents
- Known allergy or sensitivity to the test agents or components
- History of steroid response following topical administration of corticosteroids in the eye
- Wore contact lenses 48 hours prior to Visit 1
- An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
- Any significant illness that could be expected to interfere with study
- Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texan Eye Care PA
Austin, Texas, 78705
Cornea Consultants/Laser Eye Consultants of Boston
Boston, Massachusetts, 02114
Donald E. Beahm, MD
Great Bend, Kansas, 67530
Houston Eye Associates
Houston, Texas, 77025
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, 03801
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
About this study
Official title: A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
- Conditions
- Eye Infections, Postoperative Complications
- Being tested
- Prednisolone and Tobramycin, Prednisolone
- Keywords
- Cataract Extraction, Anti-Bacterial Agents, Steroids
- Medical subject headings
- Eye Infections, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone and TobramycinDrug
PrednisoloneDrug
Also called Pred Forte
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone and Tobramycin | Experimental | Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. Receives: Drug: Prednisolone and Tobramycin |
| Prednisolone | Active comparator | Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InfectionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim McNamara, PharmD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198523
- Sponsor's protocol ID
- ISTA-TP-CPK01
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension
- ClinicalTrials.gov ID
- NCT00198523
- Acronym / sponsor ID
- ISTA-TP-CPK01
- Conditions
- Eye Infections, Postoperative Complications
- Keywords
- Cataract Extraction, Anti-Bacterial Agents, Steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 20 Sep 2005 (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 demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone and Tobramycin | Experimental | Drug: Prednisolone and TobramycinPrednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. |
| Prednisolone | Active comparator | Drug: PrednisolonePrednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral cataract surgery
- Avoid disallowed medications throughout study
Key exclusion criteria (7 listed)
- Contraindications to the use of the test agents
- Known allergy or sensitivity to the test agents or components
- History of steroid response following topical administration of corticosteroids in the eye
- Wore contact lenses 48 hours prior to Visit 1
- An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
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 |
|---|---|---|
| Prednisolone and Tobramycin | Drug | Prednisolone and Tobramycin |
| PrednisoloneAlso: Pred Forte | Drug | Prednisolone |
Primary outcome
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
Time frame: 2 days
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
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 15 Mar 2013.
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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.
Tim McNamara, PharmD study director
ISTA Pharmaceuticals, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone and Tobramycin and Prednisolone in people with Eye Infections and Postoperative Complications, run by Bausch & Lomb Incorporated at 6 sites 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 7 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points (time frame: 2 days). 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 15 Mar 2013.