Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

January 31, 2012 updated by: Alcon Research

The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW1E 6AU
        • OTG Research & Consultancy
  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject must be 18 years of age or older;
  2. The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
  3. The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit

  4. The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:

    • Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
    • TFBUT measured with DET ≤ 5 seconds in at least one eye;
    • Grade 1 for meibomian gland expression in both eyes;
    • Evidence of missing meibomian glands in both eyes.

Exclusion Criteria:

  1. History or evidence of ocular or intraocular surgery in either eye within the past six months.
  2. History or evidence of serious ocular trauma in either eye within the past six months.
  3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
  4. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  5. Use of any concomitant topical ocular medications during the study period.
  6. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
  7. Participation in an investigational drug or device study within 30 days of entering this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ocular Emulsion
An Ocular Emulsion
Other: Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
Other Names:
  • Ocular Emulsion
ACTIVE_COMPARATOR: OPTIVE™
An OPTIVE™
Other: OPTIVE™
One instillation of the eye drop in each eye
Other Names:
  • Optive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the tear film break-up time using DET sodium fluorescein strips.
Time Frame: Enrollment Test visit 1
Enrollment Test visit 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.
Time Frame: Enrollment Test visit 2
Enrollment Test visit 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Optometric Technology Group Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (ESTIMATE)

June 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID11-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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