Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

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Detailed Description

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Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Systane Ultra

Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Group Type EXPERIMENTAL

Preservative-free saline solution eyedrops

Intervention Type OTHER

1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

Systane® ULTRA lubricant eyedrops

Intervention Type OTHER

Optive

OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Group Type ACTIVE_COMPARATOR

Preservative-free saline solution eyedrops

Intervention Type OTHER

1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

OPTIVE® lubricating eyedrops

Intervention Type OTHER

Interventions

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Preservative-free saline solution eyedrops

1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

Intervention Type OTHER

Systane® ULTRA lubricant eyedrops

Intervention Type OTHER

OPTIVE® lubricating eyedrops

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willing and able to attend all study visits.
* Diagnosis of dry eye, as specified in protocol.
* Uses artificial tears, as specified in protocol.

Exclusion Criteria

* Poor visual acuity, as specified in protocol.
* Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
* Any hypersensitivity or allergy to the investigational products or ingredients.
* Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
* Contact lens use within 2 weeks of Screening Visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No