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A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

NCT ID: NCT01294956

Last Updated: 2016-11-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

Detailed Description

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Conditions

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Dry Eye

Keywords

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Dry eye artificial tears corneal staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FID 115958D

Lubricant Eye Drop

Group Type EXPERIMENTAL

Lubricant Eye Drop

Intervention Type OTHER

1 drop in each eye, four times a day for 42 days

Refresh Liquigel

Lubricant Eye Drop

Group Type ACTIVE_COMPARATOR

Refresh Liquigel

Intervention Type OTHER

1 drop in each eye, four times a day for 42 days

Interventions

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Lubricant Eye Drop

1 drop in each eye, four times a day for 42 days

Intervention Type OTHER

Refresh Liquigel

1 drop in each eye, four times a day for 42 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of dry eye
* NaFl Corneal staining sum score ≥ 3 in either eye
* Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion Criteria

* No contact lenses wear throughout the study period
* Must not have had punctal plugs inserted within 30 days preceding enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.

Reference Type RESULT
PMID: 24403819 (View on PubMed)

Other Identifiers

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C-10-043

Identifier Type: -

Identifier Source: org_study_id