IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2b Controlled Study of Dosing Techniques - Part B

NCT07161011

Dry Eye

ACTIVE_NOT_RECRUITING PHASE2

Phase 2b Controlled Study

NCT07140380

Dry Eye Disease

ACTIVE_NOT_RECRUITING PHASE2

Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome

NCT03162094

Dry Eye Syndrome

UNKNOWN PHASE1/PHASE2

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT00404131

Dry Eye Disease

COMPLETED PHASE3

A Multi-Center Study Subjects With Dry Eye Syndrome

NCT01745887

Dry Eye Syndrome

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-masked

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-masked

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IVW-1001 0.1%

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Group Type EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Intervention Type DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 0.2%

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Group Type EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Intervention Type DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 Placebo

Vehicle

Group Type PLACEBO_COMPARATOR

IVW-1001 Placebo

Intervention Type DRUG

IVW-1001 Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Intervention Type DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Intervention Type DRUG

IVW-1001 Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects of any gender at least 18 years of age at the Screening Visit
2. Able to voluntarily provide written informed consent to participate in the study
3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
4. Diagnosis of Dry Eye Disease (DED)

Exclusion Criteria

1. Corneal fluorescein staining score of 4 using the NEI grading system
2. Intraocular pressure ≥23 mmHg
3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No