NCT06400459
Completed
Phase 1
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
ConditionsDry Eye Disease
Overview
- Phase
- Phase 1
- Intervention
- IVW-1001 Ophthalmic Eyelid Wipe 0.1%
- Conditions
- Dry Eye Disease
- Sponsor
- IVIEW Therapeutics Inc.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Schirmer's
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
IVW-1001 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
Intervention: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 0.2%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
Intervention: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
IVW-1001 Placebo
Vehicle
Intervention: IVW-1001 Placebo
Outcomes
Primary Outcomes
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
- Visual Acuity(29 Days)
- Total Corneal Fluorescein Staining Score in the Study Eye(Week 4)
- Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score(Week 4)
- Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score(4 weeks)
- Symptom Assessment in Dry Eye (SANDE): Global Score(4 weeks)
Study Sites (1)
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Related News
IVIEW Therapeutics' Novel Dry Eye Treatment Shows Promising Results in Phase 1/2 Trial- IVW-1001, a novel TRPM8 agonist delivered via ophthalmic eyelid wipe, demonstrated significant improvements in dry eye symptoms and corneal staining in a 150-patient Phase 1/2 trial.
- The higher dose (0.2%) formulation showed superior efficacy across multiple endpoints, with statistically significant reductions in Eye Dryness Score (-22.8 vs -18.3, p=0.0315) and corneal staining.
- The treatment exhibited a favorable safety profile with only mild to moderate adverse events, positioning IVW-1001 for advancement to pivotal trials.iView Therapeutics Completes Enrollment in Phase 1/2 Trial of IVW-1001 for Dry Eye Disease- iView Therapeutics has finished enrolling patients in its Phase 1/2 clinical trial of IVW-1001, an ophthalmic eyelid wipe for treating dry eye disease.
- The trial is a randomized, multicenter, double-masked study assessing the safety, tolerability, and efficacy of IVW-1001 at different doses compared to a placebo.
- IVW-1001 is a novel TRPM8 agonist designed to enhance tear secretion and alleviate pain by targeting the TRPM8 channel on corneal and eyelid sensory neurons.
- Topline data from the Phase 1/2 trial are expected in the first quarter of 2025, potentially offering a new treatment option for dry eye disease.