NCT02186431

Brief Summary

To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

July 7, 2014

Last Update Submit

July 8, 2016

Conditions

Keratitis

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (1)

  • Tear protein levels

    After 4-6 hours of daily wear and after one night extended wear

Study Arms (2)

history of corneal infiltrative events

EXPERIMENTAL

To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events

Device: senofilcon A

without a history of corneal infiltrative events

ACTIVE COMPARATOR

To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.

Device: senofilcon A

Interventions

senofilcon ADEVICE
Also known as: Acuvue Oasys
history of corneal infiltrative eventswithout a history of corneal infiltrative events

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Soft contact lens wearers
  • Healthy (control), or with history of infiltrative keratitis (case)
  • Has a wearable pair of glasses
  • Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism

You may not qualify if:

  • Smoker
  • Pregnant or nursing
  • Systemic disease that would effect tear proteins
  • Punctal plugs
  • Use of eye drops in the last week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY College of Optometry, Clinical Vision Research Center

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Kathryn Richdale, OD, PhD

    State University of New York College of Optometry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

US(1)