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Evaluation of Ocular Comfort With ISTA Tears vs Systane

NCT ID: NCT01650584

Last Updated: 2024-10-08

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-01-31

Brief Summary

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To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ISTA Tears

Sterile ophthalmic solution

Group Type EXPERIMENTAL

ISTA Tears

Intervention Type DRUG

sterile ophthalmic solution

Systane

Sterile ophthalmic solution

Group Type ACTIVE_COMPARATOR

Systane

Intervention Type DRUG

Sterile ophthalmic solution

Interventions

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ISTA Tears

sterile ophthalmic solution

Intervention Type DRUG

Systane

Sterile ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* OSDI \>12

Exclusion Criteria

* Presence of any active ocular disease other than dry eye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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S00231

Identifier Type: -

Identifier Source: org_study_id

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