Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 28, 2021

Primary Completion Date

December 1, 2021

Study Completion Date

December 1, 2021

Conditions
Dry Eye Disease
Interventions
DRUG

iNexin™ (0.08% aCT1)

36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.randomized 7:3 for each active concentration to Vehicle.

DRUG

iNexin™ (0.4% aCT1)

36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.

DRUG

iNexin™ (2.0% aCT1)

36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.

DRUG

Vehicle (eye drop formulation without aCT1)

"36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.~During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2)."

Trial Locations (1)

01810

Andover Eye Associates, Andover

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Xequel Bio, Inc.

OTHER

NCT05031806 - Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease | Biotech Hunter | Biotech Hunter