NCT01132287

Brief Summary

Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

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

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 21, 2016

Status Verified

January 1, 2012

Enrollment Period

7 months

First QC Date

May 26, 2010

Last Update Submit

November 18, 2016

Conditions

Contact Lens Wear

Keywords

Contact lens wearlubricant eye drops

Outcome Measures

Primary Outcomes (1)

  • Subjective Comfort

    14 days

Secondary Outcomes (2)

  • Slit Lamp

    14 Days

  • Visual Acuity

    14 Days

Study Arms (2)

1 FID 112903

EXPERIMENTAL

FID 112903

Other: FID 112903

No Intervention

NO INTERVENTION

Interventions

FID 112903OTHER

lubricant eye drop FID 112903

Also known as: Systane Ultra
1 FID 112903

Eligibility Criteria

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

You may qualify if:

  • Normal eyes

You may not qualify if:

  • Topical ocular medication use Unstable or active ocular issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • McDonald M, Schachet JL, Lievens CW, Kern JR. Systane(R) ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018.

    PMID: 24552755RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 28, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 21, 2016

Record last verified: 2012-01