Evaluation of FID 114657 on Tear Film Lipid Layer Thickness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00848068
First received: February 19, 2009
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye.


Condition Intervention
Dry Eye
Other: FID 114657
Other: OPTIVE Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • lipid layer thickness [ Time Frame: Instill assigned test article to the right eye and begin timing the examination process. Measure lipid layer thickness at 1 minute, 5 minutes, 15 minutes and 60 minutes post instillation ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
OD (Right Eye)
FID 114657 or OPTIVE
Other: FID 114657
artificial tears
Other: OPTIVE Lubricant Eye Drops
artificial tears
OS (Left eye)
FID 114657 or OPTIVE
Other: FID 114657
artificial tears
Other: OPTIVE Lubricant Eye Drops
artificial tears

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
  • Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics:

    • Positive response to the question, "Do you ever feel your eyes?";
    • Baseline LLT value of ≤75nm (OU), not varying by more than ±15 nm over the course of a 10-minute observation period, difference in LLT between the two eyes must be ≤15nm, and increase in LLT after three forceful blinks must be ≤15nm.
  • Patients must have best-corrected Snellen visual acuity of 20/70 or better in each eye.
  • Able and willing to follow study instructions.

Exclusion Criteria:

  • Use of topical ocular drops within 12 hours of the study visit; or use of a topical ocular ointment within 36 hours of the study visit. In addition, use of any concomitant topical ocular drugs during the study period.
  • 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.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History of and/or current evidence of glaucoma or ocular hypertension in either eye.
  • History of and/or current evidence of active intraocular inflammation in either eye (i.e., retina/macula/choroid).
  • History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Ocular conditions such as active acute blepharitis, conjunctival infections, iritis, conjunctival abnormalities (including pinguecula greater than 1mm in diameter, located closer than 2mm to the limbus or elevated more than 0.2mm), eyelid abnormalities (including entropion and ectropion) or any other ocular condition that may, in the opinion of the investigator, preclude the safe administration of the test articles.
  • Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to the study visit.
  • Any ocular or systemic medical condition that might influence the tear film (other than dry eye).
  • Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued a minimum of 12 hours prior to the study visit.
  • Individuals unwilling to discontinue use of cosmetics (such as eyeliner, mascara or eye shadow) or facial creams on or around the eyelids on the day of the study.
  • 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00848068     History of Changes
Other Study ID Numbers: C-07-61
Study First Received: February 19, 2009
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
lipid layer thickness

ClinicalTrials.gov processed this record on October 29, 2014