An observational study in Pseudophakia and Inflammation, sponsored by Toyos Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-22.
Sponsored by Toyos Clinic · Observational
Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
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.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 49 is below the median of 71 across 26 observational studies indexed under Pseudophakia.
Browse Pseudophakia studies →Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
Also known as: Lotemax, loteprednol
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.
Time frame: baseline to 6 weeks
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.
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
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.
Time frame: 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.
Time frame: baseline to 6 weeks
Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.
| Milestone | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Started | 49 |
| Completed | 41 |
| Not completed | 8 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lack of efficacy | 3 |
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.
| mm Hg | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| 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. | -1.8 ± 1.06 |
Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
| change in ETDRS letters read | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| ETDRS Letters Read Over Early Postoperative Period | 8.05 ± 2.14 |
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.
| units on a scale | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification | 0.25 ± 1.11 |
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.
| units on a scale | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Flare Scores in Early Postoperative Period | 0.08 ± 0.78 |
Collected over 6 weeks after phacoemulsification was performed. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | — | 0/49 (0%) | 3/49 (6.1%) |
| Event | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| increasing ocular cellEye disorders | 3/49 |
| Age, Categorical(Participants) | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 35 |
| Age, Continuous(years) | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Mean | 68.93 ± 9.61 |
| Sex: Female, Male(Participants) | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Female | 30 |
| Male | 19 |
| Region of Enrollment(participants) | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| United States | 49 |
The record gives a start of Apr 2011, a primary completion of Sep 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2018, 5 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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