Inflammation Following Ocular SurgeryPhase 1NCT03531697
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
A Phase 1 study testing Generic Loteprednol Etabonate and Reference Listed Drug (RLD) in people with Inflammation Following Ocular Surgery, run by Sandoz at 1 site in Canada.
Trial summary
This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation Following Ocular Surgery
- What is being tested?
- Generic Loteprednol Etabonate and Reference Listed Drug (RLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2018to 7 Oct 2019
- Phase
- Phase 1
- 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
- Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
- Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control [condom or diaphragm and spermicide] for the duration of the study).
- Male subjects should use medically reliable contraception methods such as condom or vasectomy.
- Subjects are able to perform the activities required by the study protocol and have provided written informed consent.
Who cannot join
- Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
- Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
- Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
- Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
- Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)
- Conditions
- Inflammation Following Ocular Surgery
- Being tested
- Generic Loteprednol Etabonate, Reference Listed Drug (RLD)
- Keywords
- Loteprednol Etabonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Loteprednol EtabonateDrug
Drug
Reference Listed Drug (RLD)Drug
Also called Loteprednol Etabonate
Drug
| Study group | Role | What they receive |
|---|---|---|
| Generic Loteprednol Etabonate - RLD | Experimental | Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD) Receives: Drug: Generic Loteprednol Etabonate; Drug: Reference Listed Drug (RLD) |
| RLD - Generic Loteprednol Etabonate | Active comparator | Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate Receives: Drug: Generic Loteprednol Etabonate; Drug: Reference Listed Drug (RLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
Measured: upon study completion, up to 1 year
Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
Measured: upon study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start26 Apr 2018
- Primary completion7 Sep 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation Following Ocular SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531697
- Sponsor's protocol ID
- SAN-LE-002
- Status last verified
- Nov 2019
- First submitted
- 20 Apr 2018
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT03531697
- Acronym / sponsor ID
- SAN-LE-002
- Conditions
- Inflammation Following Ocular Surgery
- Keywords
- Loteprednol Etabonate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 7 Sep 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 22 May 2018 (actual)
- 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.
This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Loteprednol Etabonate - RLD | Experimental | Drug: Generic Loteprednol Etabonate, Drug: Reference Listed Drug (RLD)Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD) |
| RLD - Generic Loteprednol Etabonate | Active comparator | Drug: Generic Loteprednol Etabonate, Drug: Reference Listed Drug (RLD)Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
- Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control [condom or diaphragm and spermicide] for the duration of the study).
- Male subjects should use medically reliable contraception methods such as condom or vasectomy.
- Subjects are able to perform the activities required by the study protocol and have provided written informed consent.
Key exclusion criteria (5 listed)
- Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
- Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
- Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
- Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
- Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to 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 |
|---|---|---|
| Generic Loteprednol EtabonateDrug | Drug | Generic Loteprednol Etabonate - RLD, RLD - Generic Loteprednol Etabonate |
| Reference Listed Drug (RLD)Also: Loteprednol EtabonateDrug | Drug | Generic Loteprednol Etabonate - RLD, RLD - Generic Loteprednol Etabonate |
Primary outcome
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
Time frame: upon study completion, up to 1 year
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)
Time frame: upon study completion, up to 1 year
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
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 6 Nov 2019.
- Individual participant dataSharing planned: No
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Postoperative Ocular Inflammation, Postoperative Ocular Pain
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.
Sandoz study director
Sandoz
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 Generic Loteprednol Etabonate and Reference Listed Drug (RLD) in people with Inflammation Following Ocular Surgery, run by Sandoz at 1 site in Canada.
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 5 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 6 Nov 2019. 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 Canada. 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?
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?
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC) (time frame: upon study completion, up to 1 year). 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 6 Nov 2019.