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Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Systane Ultra Lubricant Eye Drops

Hialid 0.1 Artificial Tears Eye Drops

Unisol 4 Saline Solution

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye, Ocular Retention Time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with mild to moderate dry eye as defined in the protocol.
Able and willing to follow instructions.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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.
Other protocol-defined exclusion criteria may apply.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Arm Label

Systane, Hialid, Unisol

Systane, Unisol, Hialid

Hialid, Systane, Unisol

Hialid, Unisol, Systane

Unisol, Systane, Hialid

Unisol, Hialid, Systane

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01252121

First Posted

November 30, 2010

Last Updated

October 26, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01252121

Brief Title

Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

Dry Eye, Ocular Retention Time

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Systane, Hialid, Unisol

Arm Type

Other

Arm Description

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.

Arm Title

Systane, Unisol, Hialid

Arm Type

Other

Arm Description

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.

Arm Title

Hialid, Systane, Unisol

Arm Type

Other

Arm Description

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.

Arm Title

Hialid, Unisol, Systane

Arm Type

Other

Arm Description

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.

Arm Title

Unisol, Systane, Hialid

Arm Type

Other

Arm Description

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.

Arm Title

Unisol, Hialid, Systane

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Systane Ultra Lubricant Eye Drops

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hialid 0.1 Artificial Tears Eye Drops

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Unisol 4 Saline Solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Ocular surface residence time

Description

Time Frame

Time to event

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with mild to moderate dry eye as defined in the protocol. Able and willing to follow instructions. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 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. Other protocol-defined exclusion criteria may apply.

12. IPD Sharing Statement

Learn more about this trial

Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

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