NCT00372034

Brief Summary

The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Shorter than P25 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

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

8 months

First QC Date

September 3, 2006

Last Update Submit

April 6, 2009

Conditions

Dry Eye Syndromes

Keywords

contact lensesintolerancepunctal plugstear volumeIntolerance to contact lens wear due to dryness symptoms

Outcome Measures

Primary Outcomes (3)

  • Ocular comfort after 6 hours of contact lens wear

  • Dryness sensation after 6 hours of contact lens wear

  • Tear film volume before and after 6 hours of contact lens wear

Secondary Outcomes (2)

  • Objective ocular sensitivity after 6 hours of contact lens wear

  • Tear film and contact lens osmolality after 6 hours of contact lens wear

Interventions

Temporary Collagen InsertsDEVICE

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age

You may not qualify if:

  • Corneal refractive surgery
  • Contraindications to contact lens wear
  • Latex allergy
  • Corneal hypoesthesia
  • Active corneal infection
  • Acute or sub-acute inflammation or infection of the anterior chamber of the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision CRC, Institute for Eye Research, School of Optometry and Vision Science

Sydney, New South Wales, 2033, Australia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ulrike Stahl, Dipl-Optom

    VisionCRC, School of Optometry and Vision Science, Institute for Eye Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2006

First Posted

September 6, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

AU(1)