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)
• Enrollment: 65
• Location: 1
• Arms: 3
• Actual Duration (Days): 22
• Patients Per Site Per Month: 89.9

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 Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: EM-100; Drug: Zaditor®; Drug: Vehicle	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Total Eye Care, PA	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Bausch & Lomb Incorporated
• ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2018

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: Conjunctivitis; Conjunctivitis, Allergic

Study Results

Participant Flow

Recruitment Details

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.

Arm/Group Title	EM-100	Zaditor®	Vehicle
Arm/Group Description	One 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
STARTED	51	52	27
COMPLETED	51	52	27
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	The 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 Participants	65
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

Title	Ocular Itching
Description	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

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 Title	EM-100	Zaditor®	Vehicle
Arm/Group Description	One 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 Participants	51	52	27
Measure eyes	51	52	27
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

Title	Conjunctival Redness
Description	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

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 Title	EM-100	Zaditor®	Vehicle
Arm/Group Description	One 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 Participants	51	52	27
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 Frame	1 day
Arm/Group Title	Overall Participants
Arm/Group Description	The 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
Total	0/65 (0%)
Serious Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	0/65 (0%)
Other (Not Including Serious) Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	0/65 (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.