PseudophakiaNCT01344226
Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery
An observational study of Pseudophakia and Inflammation, run by Toyos Clinic at 1 site in United States.
Trial summary
Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudophakia, Inflammation
- What is being tested?
- loteprednol 0.5% ophthalmic solution
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.
Who may be able to join
- Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation.
- Agree not to have any other ocular surgery in the study or fellow eye for duration of study.
- Have a BCVA of 20/200 or better in either eye.
- Willing/able to return for all required study visits.
- Willing/able to follow instructions from the study investigator and their staff.
- Able to self-administer test article (or have a caregiver available to instill all doses of test article).
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- If woman capable of becoming pregnant, agree to have urine pregnancy test(must be negative) at agree to use a medically acceptable form of birth control during study and for at least one week prior to and after completion of the study.
- Have read, understood, and signed the informed consent document approved by Sterling Institutional Review Board.
- Have IOP ≥ 5mmHg and ≤ 22mmHg, (in study eye) with or without anti-glaucoma therapy at the pre-operative screening visit (if > 22mmHg, adjust following pachymetry).
Who cannot join
- Have known hypersensitivity to Lotemax or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
- Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs).
- Have intraocular inflammation (i.e. cells or flare in the anterior chamber as measured on slit lamp exam) in the study eye at the screening visit.
- Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
- Have used ocular, topical, or systemic steroids within 14 days or depot steroid 30 days prior to initiation of dosing with the test article or throughout the duration of the study. Note: use of an opioid during surgery (e.g., fentanyl) is allowed.
- Have uncontrolled glaucoma or IOP >/= 27mmHg.
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- Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
- Are pregnant or nursing.
- Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Discover Vision Centers
Independence, Missouri, 64055
About this study
Official title: Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery
Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
Read the detailed description
This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article.
In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.
- Conditions
- Pseudophakia, Inflammation
- Being tested
- loteprednol 0.5% ophthalmic solution
- Keywords
- steroid responder
- Medical subject headings
- Pseudophakia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loteprednol 0.5% ophthalmic solutionDrug
Also called Lotemax, loteprednol
Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
Measured: baseline to 6 weeks
Secondary outcomes (3)
ETDRS Letters Read Over Early Postoperative Period
Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
Measured: change in ETDRS letters read baseline to 6 weeks
Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.
Measured: baseline to 6 weeks
Flare Scores in Early Postoperative Period
Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.
Measured: baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
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 PseudophakiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Toyos, Toyos Clinic
- Investigators
- Melissa Toyos, MD, Principal investigator, Discover Vision Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344226
- Sponsor's protocol ID
- MMC-2011A
- Status last verified
- Jan 2018
- First submitted
- 27 Apr 2011
- Last updated
- 22 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT01344226
- Acronym / sponsor ID
- MMC-2011A
- Conditions
- Pseudophakia, Inflammation
- Keywords
- steroid responder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Posted 22 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
Detailed description
This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article.
In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.
Key inclusion criteria (9 listed)
- Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation.
- Agree not to have any other ocular surgery in the study or fellow eye for duration of study.
- Have a BCVA of 20/200 or better in either eye.
- Willing/able to return for all required study visits.
- Willing/able to follow instructions from the study investigator and their staff.
Key exclusion criteria (9 listed)
- Have known hypersensitivity to Lotemax or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
- Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs).
- Have intraocular inflammation (i.e. cells or flare in the anterior chamber as measured on slit lamp exam) in the study eye at the screening visit.
- Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
- Have used ocular, topical, or systemic steroids within 14 days or depot steroid 30 days prior to initiation of dosing with the test article or throughout the duration of the study. Note: use of an opioid during surgery (e.g., fentanyl) is allowed.
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 |
|---|---|---|
| loteprednol 0.5% ophthalmic solutionAlso: Lotemax, loteprednolLotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days. | Drug | – |
Primary outcome
Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
Time frame: baseline to 6 weeks
Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
3 secondary outcomes
ETDRS Letters Read Over Early Postoperative Period
Time frame: change in ETDRS letters read baseline to 6 weeks
Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
Time frame: baseline to 6 weeks
Flare Scores in Early Postoperative Period
Time frame: baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click on "Current Studies"Link provided by the sponsor.
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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.
Melissa Toyos, MD principal investigator
Discover Vision Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakia and Inflammation, run by Toyos Clinic 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 9 inclusion and 9 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 22 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2018). 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?
Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation. (time frame: baseline to 6 weeks). 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 22 Oct 2018.