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

NCT ID: NCT01252121

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye Syndrome

Keywords

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Dry Eye Ocular Retention Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Systane, Hialid, Unisol

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Systane, Unisol, Hialid

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Hialid, Systane, Unisol

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Hialid, Unisol, Systane

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Unisol, Systane, Hialid

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Unisol, Hialid, Systane

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.

Group Type OTHER

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

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

Hialid 0.1 Artificial Tears Eye Drops

Intervention Type OTHER

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

Unisol 4 Saline Solution

Intervention Type OTHER

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

Interventions

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Systane Ultra Lubricant Eye Drops

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

Intervention Type OTHER

Hialid 0.1 Artificial Tears Eye Drops

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

Intervention Type OTHER

Unisol 4 Saline Solution

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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CS-10-01

Identifier Type: OTHER

Identifier Source: secondary_id

RDG-10-275

Identifier Type: -

Identifier Source: org_study_id