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Completed

NCT Number: NCT01368198

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OTG Research & Consultancy, London, England, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History or evidence of serious ocular trauma in either eye within the past six months.
  • Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
  • 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.
  • Use of any concomitant topical ocular medications during the study period.
  • Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
  • Participation in an investigational drug or device study within 30 days of entering this study.

Treatment and study plan

Systane Balance Lubricating Eye Drops

Other

One instillation of the eye drop in each eye

Other names: Ocular Emulsion

OPTIVE™

Other

One instillation of the eye drop in each eye

Other names: Optive

Primary outcomes

  1. Measurement of the tear film break-up time using DET sodium fluorescein strips.

    Time frame: Enrollment Test visit 1

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • Optometric Technology Group Ltd

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2011
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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