A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT03489941
Collaborator
ORA, Inc. (Industry)
65
Enrollment
1
Location
3
Arms
22
Actual Duration (Days)
89.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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®)
Actual Study Start Date :
Apr 7, 2018
Actual Primary Completion Date :
Apr 29, 2018
Actual Study Completion Date :
Apr 29, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: EM-100

One drop of EM-100 in either the right or left eye once on Day 1.

Drug: EM-100
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Experimental: Zaditor®

One drop of Zaditor® in either the right or left eye once on Day 1.

Drug: Zaditor®
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Experimental: Vehicle

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.

Outcome Measures

Primary Outcome Measures

  1. Ocular Itching [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.

Secondary Outcome Measures

  1. Conjunctival Redness [7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Total Eye Care, PAMemphisTennesseeUnited States38119

Sponsors and Collaborators

  • Bausch & Lomb Incorporated
  • ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03489941
Other Study ID Numbers:
  • 17-100-0011
First Posted:
Apr 6, 2018
Last Update Posted:
May 17, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThere 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.
Pre-assignment Detail
Arm/Group TitleEM-100Zaditor®Vehicle
Arm/Group DescriptionOne drop of EM-100 in either the right or left eye once on Day 1. EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Zaditor® in either the right or left eye once on Day 1. Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Vehicle in either the right or left eye once on Day 1. Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Period Title: Overall Study
STARTED515227
COMPLETED515227
NOT COMPLETED000

Baseline Characteristics

Arm/Group TitleOverall Participants
Arm/Group DescriptionThe 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye). Demographic data were not collected by treatment or by eye.
Overall Participants65
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
44.4
(12.16)
Sex: Female, Male (Count of Participants)
Female
44
67.7%
Male
21
32.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
36
55.4%
White
29
44.6%
More than one race
0
0%
Unknown or Not Reported
0
0%
Iris color (Count of Participants)
Black
1
1.5%
Blue
8
12.3%
Brown
46
70.8%
Hazel
6
9.2%
Green
4
6.2%

Outcome Measures

1. Primary Outcome
TitleOcular Itching
DescriptionOcular 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 Frame3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Outcome Measure Data

Analysis Population Description
The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye).
Arm/Group TitleEM-100Zaditor®Vehicle
Arm/Group DescriptionOne drop of EM-100 in either the right or left eye once on Day 1. EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Zaditor® in either the right or left eye once on Day 1. Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Vehicle in either the right or left eye once on Day 1. Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Measure Participants515227
Measure eyes515227
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)
2. Secondary Outcome
TitleConjunctival Redness
DescriptionThe 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 Frame7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Outcome Measure Data

Analysis Population Description
The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye).
Arm/Group TitleEM-100Zaditor®Vehicle
Arm/Group DescriptionOne drop of EM-100 in either the right or left eye once on Day 1. EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Zaditor® in either the right or left eye once on Day 1. Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.One drop of Vehicle in either the right or left eye once on Day 1. Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Measure Participants515227
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)

Adverse Events

Time Frame1 day
Adverse Event Reporting Description
Arm/Group TitleOverall Participants
Arm/Group DescriptionThe 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye).
All Cause Mortality
Overall Participants
Affected / at Risk (%)# Events
Total0/65 (0%)
Serious Adverse Events
Overall Participants
Affected / at Risk (%)# Events
Total0/65 (0%)
Other (Not Including Serious) Adverse Events
Overall Participants
Affected / at Risk (%)# Events
Total0/65 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact sponsor directly for details.

Results Point of Contact

Name/TitleHeleen DeCory
OrganizationBausch & Lomb
Phone(585) 338-8161
Emailheleen.decory@bausch.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03489941
Other Study ID Numbers:
  • 17-100-0011
First Posted:
Apr 6, 2018
Last Update Posted:
May 17, 2021
Last Verified:
Apr 1, 2021