Allergic ConjunctivitisPhase 3NCT03489941
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
A Phase 3 study testing EM-100 and Zaditor® in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- EM-100 and Zaditor®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2018to 29 Apr 2018
- Phase
- Phase 3
- 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
Who may be able to join
- be at least 18 years old
- have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
- be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
- be willing to avoid contact lens use
- be willing to have a pregnancy test
- must be able to read an eye chart from 10 feet away
Who cannot join
- must not have any allergies to the study medications
- must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
- Conditions
- Allergic Conjunctivitis
- Being tested
- EM-100, Zaditor®, Vehicle
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EM-100Drug
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Zaditor®Drug
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
VehicleDrug
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
| Study group | Role | What they receive |
|---|---|---|
| EM-100 | Experimental | One drop of EM-100 in either the right or left eye once on Day 1. Receives: Drug: EM-100 |
| Zaditor® | Experimental | One drop of Zaditor® in either the right or left eye once on Day 1. Receives: Drug: Zaditor® |
| Vehicle | Experimental | One drop of Vehicle in either the right or left eye once on Day 1. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Secondary outcomes (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).
Measured: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start7 Apr 2018
- Primary completion29 Apr 2018
- Study completion29 Apr 2018
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 Allergic ConjunctivitisStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489941
- Sponsor's protocol ID
- 17-100-0011
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2018
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)
- ClinicalTrials.gov ID
- NCT03489941
- Acronym / sponsor ID
- 17-100-0011
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 29 Apr 2018 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Posted 17 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EM-100 | Experimental | Drug: EM-100One drop of EM-100 in either the right or left eye once on Day 1. |
| Zaditor® | Experimental | Drug: Zaditor®One drop of Zaditor® in either the right or left eye once on Day 1. |
| Vehicle | Experimental | Drug: VehicleOne drop of Vehicle in either the right or left eye once on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be at least 18 years old
- have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
- be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
- be willing to avoid contact lens use
- be willing to have a pregnancy test
Key exclusion criteria (3 listed)
- must not have any allergies to the study medications
- must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial
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 |
|---|---|---|
| EM-100Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. | Drug | EM-100 |
| Zaditor®Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. | Drug | Zaditor® |
| VehicleSubjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. | Drug | Vehicle |
Primary outcome
Ocular Itching
Time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
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.
1 secondary outcome
Conjunctival Redness
Time frame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EM-100 and Zaditor® in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated 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 6 inclusion and 3 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 8 Jun 2023. 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.
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?
Yes. Results are posted in the registry (first posted 17 May 2021). 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?
Ocular Itching (time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1). 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 8 Jun 2023.