NCT07639034

Brief Summary

The primary objective of this study is to show that consistent use of Systane PRO over a 30 period will significantly improve the signs and symptoms of Dry Eye Disease and decrease patients' ocular surface disease index score for patients diagnosed with mild-moderate (DED).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 3, 2026

Last Update Submit

June 4, 2026

Conditions

Dry Eye Disease (DED)

Keywords

dry eyes,

Outcome Measures

Primary Outcomes (1)

  • Change in OSDI Score

    Change in OSDI Score will be analyzed with a Wilcoxon signed-rank test comparing Baseline vs. Follow-up. Median change and the proportion of subjects with a ≥4.5-point decrease in score will be reported.

    From enrollment to the end of participation at 28 days

Study Arms (1)

The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and

ACTIVE COMPARATOR
Drug: Systane Pro Topical Ophthalmic

Interventions

Systane Pro Topical OphthalmicDRUG

To show that consistent use of Systane PRO will significantly improve the signs and symptoms of Dry Eye Disease in patients with mild-moderate DED.

The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and older with mild-moderate DED (as determined by an OSDI score between 13-22).

You may not qualify if:

  • Patients unwilling to discontinue all concomitant ophthalmic medications and dry eye therapies for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gordon Schanzlin New Vision Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 10, 2026

Study Start

November 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations

US(1)