RECRUITING

Phase 2b Controlled Study of Dosing Techniques

Description

Double-masked two period controlled trial of three eyelid wipe dosing techniques

Conditions

Study Overview

Study Details

Study overview

Double-masked two period controlled trial of three eyelid wipe dosing techniques

Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease

Phase 2b Controlled Study of Dosing Techniques

Condition
Dry Eye Disease
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Eye Research Foundation, Newport Beach, California, United States, 92663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Self-reported diagnosis of DED in one or both eyes
  • * BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
  • * For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
  • * History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
  • * Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit
  • * Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
  • * IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
  • * History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IVIEW Therapeutics Inc.,

Study Record Dates

2025-12-31