NCT00607776

Brief Summary

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

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

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

First QC Date

December 19, 2007

Last Update Submit

January 31, 2025

Conditions

Dry Eye

Keywords

dry, eyesAmelioration of dry eye symptoms

Outcome Measures

Primary Outcomes (1)

  • Subjective ocular comfort

    1 Month

Secondary Outcomes (1)

  • Vision quality

    1 Month

Study Arms (2)

1

ACTIVE COMPARATOR

Systane

Drug: Systane

2

EXPERIMENTAL

Blink tears

Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400

Interventions

(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400DRUG

Drops

2
SystaneDRUG

Drops

1

Eligibility Criteria

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

You may qualify if:

  • Mild to moderate dry eye
  • over 18

You may not qualify if:

  • No concurrent ocular disease or meds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye SyndromesXerophthalmia

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesConjunctival Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Eric Donnenfeld, M.D.

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2007

First Posted

February 6, 2008

Study Start

January 1, 2007

Study Completion

April 1, 2007

Last Updated

February 3, 2025

Record last verified: 2025-01