NCT05031806

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

A Single-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of iNexin™ Eye Drops Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Xequel Bio, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of iNexin™ The secondary objective is to compare the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.

Detailed description

The clinical hypothesis for this study is that iNexin™ demonstrates safety and tolerability in subjects with DED and can be evaluated for further safety and efficacy measures compared to vehicle. This is a Phase 1b single-center, randomized, double masked, vehicle controlled clinical study to assess the safety and exploratory efficacy of iNexin™ compared to vehicle in subjects with Dry Eye Disease. A total of 36 subjects, at least 18 years of age, with a subject-reported history of DED in both eyes and meeting all other study eligibility criteria will be randomized to receive treatment with iNexin™ or vehicle. An individual subject's participation time is expected to be approximately 24 days. 36 eligible subjects will be randomized in a 2:1 allocation for each of three concentrations of iNexin™ to Vehicle, to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). There will also be a 1-day post-final dose follow-up visit (Visit 5). During a 7-day study run-in period prior to randomization (from Visit 1 to the evening before Visit 2), all subjects will receive Vehicle eye drops (Vehicle) bilaterally at the same dosing frequency as iNexin™ (BID).

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-09-28
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-09-02
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study