NCT00395759

Brief Summary

The purpose of this study is to investigate how the addition of a new artificial tear product when applied to the tear layer affects contrast sensitivity and optical aberrations over time. We will also determine if there are any adverse effects associated with drop instillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

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

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 23, 2007

Status Verified

October 1, 2007

First QC Date

November 2, 2006

Last Update Submit

October 21, 2007

Conditions

Dry Eye Disease

Keywords

contrast sensitivity

Outcome Measures

Primary Outcomes (3)

  • Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use

  • Dry eye questionnaire before and at 1 and 2 weeks after artificial tear use

  • Slit lamp exam before and at 1 and 2 weeks after artificial tear use

Interventions

Optiva artificial tear by AllerganDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty subjects free from ocular pathology will be chosen. Ten of the subjects will have a normal tear layer, ten will have a mild dry eye, and ten will have a moderate/severe dry eye. All subjects will be over the age of 18. Best corrected visual acuities will be at least 20/25 on a standard Snellen acuity chart at distance.

You may not qualify if:

  • Subjects will be excluded from this project if they have, or during the course of the experiment they develop, an allergy to the eye drops used in this project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Related Publications (1)

  • Thai LC, Tomlinson A, Ridder WH. Contact lens drying and visual performance: the vision cycle with contact lenses. Optom Vis Sci. 2002 Jun;79(6):381-8. doi: 10.1097/00006324-200206000-00012.

    PMID: 12086305BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • William Ridder, OD. PhD

    Southern California College of Optometry at Marshall B. Ketchum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 3, 2006

Study Start

September 1, 2005

Study Completion

September 1, 2007

Last Updated

October 23, 2007

Record last verified: 2007-10

Locations

US(1)