Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

NCT ID: NCT01335126

Last Updated: 2011-04-14

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test

Group Type EXPERIMENTAL

Emulsion type artificial tear

Intervention Type OTHER

2 types of artificial tears

Interventions

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Emulsion type artificial tear

2 types of artificial tears

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 18 and over inclusive.
* Males or females
* Patient is in generally good \& stable overall health.
* Patient likely to comply with study guidelines \& study visits.
* Informed consent signed.
* OSDI score \>18 OR
* TBUT \<10 seconds

Exclusion Criteria

* Corneal refractive surgery or contact lens wear within 6 months of this study.
* Current use of Restasis
* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
* Pregnant or lactating women.
* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Hom, Milton M., OD, FAAO

INDIV

Sponsor Role lead

Responsible Party

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Private Practice

Principal Investigators

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Milton M Hom, OD FAAO

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Other Identifiers

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AG9965-007

Identifier Type: -

Identifier Source: org_study_id

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