Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

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

PHASE3

Total Enrollment

1936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

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Detailed Description

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium Hyaluronate

Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Group Type EXPERIMENTAL

Sodium Hyaluronate Ophthalmic Solution, 0.18%

Intervention Type DRUG

Vehicle

Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Inactive ingredients used as run-in and placebo comparator

Interventions

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Sodium Hyaluronate Ophthalmic Solution, 0.18%

Intervention Type DRUG

Vehicle

Inactive ingredients used as run-in and placebo comparator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented history of dry eyes for at least 3 months.
* Ocular discomfort due to dry eyes.
* Presence of corneal and conjunctival staining.

Exclusion Criteria

* Women who are pregnant or lactating.
* Contact lens wear within 1 week before Screening and during the study.
* Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
* Punctal plugs or punctal occlusion initiated within 3 months of screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No