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

This study has been completed.
Sponsor:
Collaborator:
Optometric Technology Group Ltd
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01368198
First received: May 6, 2011
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Dry Eye
Other: Systane Balance Lubricating Eye Drops
Other: OPTIVE™

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Measurement of the tear film break-up time using DET sodium fluorescein strips. [ Time Frame: Enrollment Test visit 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ocular Emulsion
An Ocular Emulsion
Other: Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
Other Names:
  • Systane Balance Lubricating Eye Drops
  • Ocular Emulsion
Active Comparator: OPTIVE™
An OPTIVE™
Other: OPTIVE™
One instillation of the eye drop in each eye
Other Name: Optive

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368198

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
United Kingdom
OTG Research & Consultancy
London, England, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Alcon Research
Optometric Technology Group Ltd
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01368198     History of Changes
Other Study ID Numbers: ID11-10
Study First Received: May 6, 2011
Last Updated: January 31, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
Ocular Emulsion
OPTIVE™ Lubricant
Tear Film Break Up Time

Additional relevant MeSH terms:
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014