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Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers

NCT ID: NCT01339936

Last Updated: 2013-11-28

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

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.

Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Investigational eye drop

Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness

Group Type EXPERIMENTAL

Carboxymethylcellulose sodium, glycerin and polysorbate 80

Intervention Type DEVICE

1 drop in each eye three times a day for a period of 30 (± 4) days

Interventions

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Carboxymethylcellulose sodium, glycerin and polysorbate 80

1 drop in each eye three times a day for a period of 30 (± 4) days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mild or greater dry eye symptoms.
* Evidence of evaporative dry eye

Exclusion Criteria

* Known allergy or sensitivity to the study product(s) or its components
* Current contact lens wearer
* Systemic or ocular allergies
* Use of systemic medication which might have ocular side effects.
* Any ocular infection.
* Use of ocular medication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Optometric Technology Group Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OTG Research & Consultancy

London, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AG9965-005 ID 10-12

Identifier Type: -

Identifier Source: org_study_id