Trial Outcomes & Findings for A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle (NCT NCT03489941)

Last Updated: 2023-06-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Results posted on

2023-06-08

Participant Flow

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.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	EM-100 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.	Zaditor® 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.	Vehicle 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.
Overall Study STARTED	51 51	52 52	27 27
Overall Study COMPLETED	51 51	52 52	27 27
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=65 Participants 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.
Age, Continuous	44.4 years STANDARD_DEVIATION 12.16 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Iris color Black	1 Participants n=5 Participants
Iris color Blue	8 Participants n=5 Participants
Iris color Brown	46 Participants n=5 Participants
Iris color Hazel	6 Participants n=5 Participants
Iris color Green	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Population: 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).

Outcome measures

Outcome measures
Measure	EM-100 n=51 eyes 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.	Zaditor® n=52 eyes 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.	Vehicle n=27 eyes 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.
Ocular Itching 3 minutes post CAC	0.81 score on a scale Standard Deviation 0.787	0.79 score on a scale Standard Deviation 0.750	1.98 score on a scale Standard Deviation 0.935
Ocular Itching 5 minutes post CAC	1.09 score on a scale Standard Deviation 1.047	1.04 score on a scale Standard Deviation 0.989	2.17 score on a scale Standard Deviation 1.00
Ocular Itching 7 minutes post CAC	1.17 score on a scale Standard Deviation 1.103	1.04 score on a scale Standard Deviation 1.047	2.22 score on a scale Standard Deviation 1.032

SECONDARY outcome

Timeframe: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

Population: 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).

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).

Outcome measures

Outcome measures
Measure	EM-100 n=51 Participants 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.	Zaditor® n=52 Participants 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.	Vehicle n=27 Participants 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.
Conjunctival Redness 20 minutes post-CAC	2.16 score on a scale Standard Deviation 0.857	2.24 score on a scale Standard Deviation 0.704	2.46 score on a scale Standard Deviation 0.784
Conjunctival Redness 7 minutes post-CAC	2.13 score on a scale Standard Deviation 0.824	2.14 score on a scale Standard Deviation 0.743	2.72 score on a scale Standard Deviation 0.725
Conjunctival Redness 15 minutes post-CAC	2.25 score on a scale Standard Deviation 0.783	2.29 score on a scale Standard Deviation 0.737	2.61 score on a scale Standard Deviation 0.847

Adverse Events

Overall Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heleen DeCory

Bausch & Lomb

Phone: (585) 338-8161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER