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

NCT05031806 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2021-OCLR-01bCDMRP-VR190131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Evaluation of the safety of iNexin™

  Assessed using: Visual Acuity (VA) (ETDRS), Slit-lamp biomicroscopy, Adverse Event Query, Dilated Fundoscopy Interocular Pressure

  Through study completion, an average of 24 days

• Evaluation of the tolerability of iNexin™

  Assessed using: Ora Calibra Drop Comfort Assessments

  Through study completion, an average of 24 days

Secondary Outcomes (1)

• Comparison of the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease

  Through study completion, an average of 24 days

Study Arms (4)

iNexin™ (0.08% aCT1)

EXPERIMENTAL

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).

Drug: iNexin™ (0.08% aCT1)

iNexin™ (0.4% aCT1)

EXPERIMENTAL

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).

Drug: iNexin™ (0.4% aCT1)

iNexin™ (2.0% aCT1)

EXPERIMENTAL

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).

Drug: iNexin™ (2.0% aCT1)

Vehicle (eye drop formulation without aCT1)

PLACEBO COMPARATOR

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).

Drug: Vehicle (eye drop formulation without aCT1)

Interventions

iNexin™ (0.08% aCT1) DRUG

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.

iNexin™ (0.08% aCT1)

iNexin™ (0.4% aCT1) DRUG

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.

iNexin™ (0.4% aCT1)

iNexin™ (2.0% aCT1) DRUG

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.

iNexin™ (2.0% aCT1)

Vehicle (eye drop formulation without aCT1) DRUG

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).

Vehicle (eye drop formulation without aCT1)

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all the following requirements to be eligible for enrollment into the study.
• Be at least 18 years of age;
• Provide written informed consent;
• Have a self-reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms for at least 6 months prior to Visit 1;
• Report a score of ≥ 2 according to a 0-5 point scale in at least one symptom of the Ora Calibra Ocular Discomfort \& 4-Symptom Questionnaire pre-CAE at Visits 1 and 2;
• Have a conjunctival redness score of ≥ 1 according to a 0-4 point scale in at least one eye at Visits 1 and 2;
• Have a tear film break-up time (TFBUT) \>1 and \< 7 seconds in at least one eye pre-CAE at Visit 1 and 2;
• Have an unanesthetized Schirmer's Test score of ≤ 10 mm and ≥ 1 mm in at least one eye pre-CAE at Visits 1 and 2;
• Have a corneal fluorescein staining sum of ≥ 6 according to a 0-4 point scale (sum of inferior, superior, and central) in at least one eye pre-CAE at Visits 1 and 2;
• Have a central corneal fluorescein staining score of ≥ 1 according to a 0-4 point in at least one eye pre-CAE at Visits 1 and 2;
• Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions of the conjunctiva according to a 0-4 point scale in at least one eye pre-CAE at Visits 1 and 2;
• Demonstrate a response to the CAE at Visits 1 and 2 as defined by:
• Having at least a ≥ 1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure; and
• Reporting an Ocular Discomfort score ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye).

You may not qualify if:

• Subjects may not participate in the study if any of the following criteria are met:
• Unable or unwilling to follow instructions, including participation in all study assessments and visits;
• Have active blepharitis, meibomian gland dysfunction (MGD) or lid margin inflammation that required any topical or systemic antibiotics or topical steroids or other prescription medical treatment or treatment with hypochlorous acid wipes within the last 3 months prior to Visit 1 or will require such treatment during the trial.
• Any other therapy such as lid scrubs, lid wipes, warm compresses have to be stable within the last 3 months prior to Visit 1 and the subject should be willing to continue those therapies through the trial
• Have active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have a significant ocular lesion that the investigator feels might affect ocular surface staining score;
• Have worn contact lenses within 14 days of Visit 1 or anticipate using contact lenses during the study;
• Have previously had laser-assisted in situ keratomileusis (LASIK) or any other Laser refractive surgery within the last 12 months or any other ocular surgeries within the last 6 months;
• Have any planned ocular and/or lid surgeries over the study period;
• Current smoker (includes tobacco, marijuana, or vaping) or has smoked within 6 months of Visit 1;
• Has dry eye secondary to known systemic diseases or comorbidities:
• Previous diagnosis of graft versus host disease or cicatrizing conjunctivitis (e.g., Steven-Johnson Syndrome, mucous membrane pemphigoid, trachoma, trauma);
• Anatomical or neurological lid closure problems (e.g., Bell's palsy, cicatricial ectropion, Alzheimer's disease, Parkinson's disease);
• Has dry eye secondary to other ocular surface diseases or ocular surgery:

Sponsors & Collaborators

• Xequel Bio, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

TRAF3IP2 protein, human

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 2, 2021
• Study Start: September 28, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)