NCT00673959

Brief Summary

To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

Trial Health

100
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

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

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 10, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

May 2, 2008

Results QC Date

September 10, 2009

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry eyeartificial tears

Outcome Measures

Primary Outcomes (1)

  • Drop Comfort Upon Instillation

    Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.

    upon instillation

Study Arms (2)

Lubricant Eye Drop FID 111421

EXPERIMENTAL

Lubricant Eye Drop FID 111421 1 drop each eye one time

Other: Lubricant Eye Drop FID 111421

Optive Lubricant Eye Drop

ACTIVE COMPARATOR

Optive Lubricant Eye Drop 1 drop each eye one time

Other: Optive Lubricant Eye Drop

Interventions

Lubricant Eye Drop FID 111421OTHER

Lubricant Eye Drop FID 111421 1 drop each eye one time

Lubricant Eye Drop FID 111421
Optive Lubricant Eye DropOTHER

Optive Lubricant Eye Drop 1 drop each eye one time

Optive Lubricant Eye Drop

Eligibility Criteria

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

You may qualify if:

  • Documented diagnosis of dry eye
  • Must not have worn contact lenses for 1 week preceding enrollment

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 7, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Last Updated

February 2, 2012

Results First Posted

March 10, 2010

Record last verified: 2012-01