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

NCT03489941 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 17-100-0011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Conjunctival Redness

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

Study Arms (3)

EM-100

EXPERIMENTAL

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

Drug: EM-100

Zaditor®

EXPERIMENTAL

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

Drug: Zaditor®

Vehicle

EXPERIMENTAL

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

Drug: Vehicle

Interventions

EM-100 DRUG

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

EM-100

Zaditor® DRUG

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

Zaditor®

Vehicle DRUG

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

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead
• ORA, Inc.: collaborator

Study Sites (1)

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

ketotifen fumarate ophthalmic solution

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Heleen DeCory
• Organization: Bausch & Lomb

heleen.decory@bausch.com

(585) 338-8161

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: April 7, 2018
• Primary Completion: April 29, 2018
• Study Completion: April 29, 2018
• Last Updated: June 8, 2023
• Results First Posted: May 17, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)