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Completed

NCT Number: NCT06400459

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

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

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Houston Eye Associates

Houston, Texas, 77025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Drug

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Drug

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 Placebo

Drug

IVW-1001 Placebo

Primary outcomes

  1. Schirmer's

    Time frame: 29 Days

    Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)

Secondary outcomes

  1. Visual Acuity

    Time frame: 29 Days

    Mean change from baseline in best corrected visual acuity

  2. Total Corneal Fluorescein Staining Score in the Study Eye

    Time frame: Week 4

    Change from baseline in score on a scale (0 - none - to 20 - severe)

  3. Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score

    Time frame: Week 4

    Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)

  4. Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score

    Time frame: 4 weeks

    Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)

  5. Symptom Assessment in Dry Eye (SANDE): Global Score

    Time frame: 4 weeks

    Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)

Sponsors and collaborators

Lead sponsor

IVIEW Therapeutics Inc.

Industry

Registry information

Official study title

Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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