A Phase 3 interventional study of EM-100 and Zaditor® in Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 65 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted after Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
One drop of EM-100 in either the right or left eye once on Day 1.
Drug: EM-100
One drop of Zaditor® in either the right or left eye once on Day 1.
Drug: Zaditor®
One drop of Vehicle in either the right or left eye once on Day 1.
Drug: Vehicle
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Ocular Itching
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
Time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Conjunctival Redness
The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).
Time frame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
There were 65 participants enrolled (130 eyes). 38 participants received EM-100 in one eye and Zaditor in the other eye. 13 participants received EM-100 in one eye and vehicle in the other eye. 14 participants received Zaditor in one eye and vehicle in the other eye. Thus, of 65 participants, 51 received EM-100 in one of their eyes, 52 received Zaditor in one of their eyes, and 27 received vehicle in one of their eyes. Each participant received 2 of the 3 study treatments, one in each eye.
| Milestone | EM-100 | Zaditor® | Vehicle |
|---|---|---|---|
| Started | 51 | 52 | 27 |
| Completed | 51 | 52 | 27 |
| Not completed | 0 | 0 | 0 |
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
| score on a scale | EM-100 | Zaditor® | Vehicle |
|---|---|---|---|
| 3 minutes post CAC | 0.81 ± 0.787 | 0.79 ± 0.750 | 1.98 ± 0.935 |
| 5 minutes post CAC | 1.09 ± 1.047 | 1.04 ± 0.989 | 2.17 ± 1.00 |
| 7 minutes post CAC | 1.17 ± 1.103 | 1.04 ± 1.047 | 2.22 ± 1.032 |
The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).
| score on a scale | EM-100 | Zaditor® | Vehicle |
|---|---|---|---|
| 7 minutes post-CAC | 2.13 ± 0.824 | 2.14 ± 0.743 | 2.72 ± 0.725 |
| 15 minutes post-CAC | 2.25 ± 0.783 | 2.29 ± 0.737 | 2.61 ± 0.847 |
| 20 minutes post-CAC | 2.16 ± 0.857 | 2.24 ± 0.704 | 2.46 ± 0.784 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Participants | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Age, Continuous(years) | Overall Participants |
|---|---|
| Mean | 44.4 ± 12.16 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 44 |
| Male | 21 |
| Race (NIH/OMB)(Participants) | Overall Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 36 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Iris color(Participants) | Overall Participants |
|---|---|
| Black | 1 |
| Blue | 8 |
| Brown | 46 |
| Hazel | 6 |
| Green | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Apr 2018, 0 months.
Results were first posted in May 2021, 3 years after primary completion. A results delay was requested in Sep 2020.
Of 21 phase 3 interventional studies under Conjunctivitis, Allergic, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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