ACTIVE_NOT_RECRUITING

Phase 2b Controlled Study

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08-20

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07140380

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.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Eye Research Foundation

Newport Beach, California, 92663

United States

Collaborators and Investigators

Sponsor: IVIEW Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-20

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-08-20

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

dry eye disease

Additional Relevant MeSH Terms

Dry Eye Disease