NCT01252121

Brief Summary

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 30, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

November 30, 2010

Last Update Submit

October 26, 2012

Conditions

Dry Eye Syndrome

Keywords

Dry EyeOcular Retention Time

Outcome Measures

Primary Outcomes (1)

  • Ocular surface residence time

    Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.

    Time to event

Study Arms (6)

Systane, Hialid, Unisol

OTHER

1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Systane, Unisol, Hialid

OTHER

1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Hialid, Systane, Unisol

OTHER

1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Hialid, Unisol, Systane

OTHER

1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Unisol, Systane, Hialid

OTHER

1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Unisol, Hialid, Systane

OTHER

1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.

Other: Systane Ultra Lubricant Eye DropsOther: Hialid 0.1 Artificial Tears Eye DropsOther: Unisol 4 Saline Solution

Interventions

Systane Ultra Lubricant Eye DropsOTHER

One drop in study eye, one time, during office visit.

Hialid, Systane, UnisolHialid, Unisol, SystaneSystane, Hialid, UnisolSystane, Unisol, HialidUnisol, Hialid, SystaneUnisol, Systane, Hialid
Hialid 0.1 Artificial Tears Eye DropsOTHER

One drop in study eye, one time, during office visit.

Hialid, Systane, UnisolHialid, Unisol, SystaneSystane, Hialid, UnisolSystane, Unisol, HialidUnisol, Hialid, SystaneUnisol, Systane, Hialid
Unisol 4 Saline SolutionOTHER

One drop in study eye, one time, during office visit.

Hialid, Systane, UnisolHialid, Unisol, SystaneSystane, Hialid, UnisolSystane, Unisol, HialidUnisol, Hialid, SystaneUnisol, Systane, Hialid

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with mild to moderate dry eye as defined in the protocol.
  • Able and willing to follow instructions.

You may not qualify if:

  • Any medical condition that may affect the results of the study.
  • History or evidence of ocular or intraocular surgery within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • Use of concomitant topical ocular medications during the study period.
  • Ocular conditions that may preclude safe administration of the test article.
  • Unwilling to discontinue contact lens wear during the study period.
  • Participation in an investigational drug or device study within 30 days of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 2, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 30, 2012

Record last verified: 2012-05