Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

NCT ID: NCT00761202

Last Updated: 2013-11-19

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

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-06-30

Brief Summary

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This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Optive Eyedrops

Group Type ACTIVE_COMPARATOR

A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®

Intervention Type DRUG

Eyedrops as required, but at least 3 times per day

2

Hylocomod Eyedrops

Group Type ACTIVE_COMPARATOR

Sodium hyaluronate

Intervention Type DRUG

Eyedrops as required, but at least 3 times per day

Interventions

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A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®

Eyedrops as required, but at least 3 times per day

Intervention Type DRUG

Sodium hyaluronate

Eyedrops as required, but at least 3 times per day

Intervention Type DRUG

Other Intervention Names

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Optive™ Eyedrops Hylocomod

Eligibility Criteria

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Inclusion Criteria

* 18 years or over
* Contact lens wearer, spectacle wearer or non-spectacle wearer
* Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
* Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
* Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria

* Previously used Hylocomod or Optive eyedrops
* Systemic allergy or eye allergy
* Systemic disease which might have an ocular component and/or interfere with contact lens wear
* Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
* Systemic medication which might have eye side effects and or interfere with contact lens wear
* Eye infection or use of eye medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AGN/OPH/DE/002

Identifier Type: -

Identifier Source: org_study_id