Evaluation of FID 114657 on Tear Film Lipid Layer Thickness
February 1, 2012 updated by: Alcon Research
To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
No
Genders Eligible for Study
All
Description
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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: OD (Right Eye)
FID 114657 or OPTIVE
|
artificial tears
artificial tears
|
|
Other: OS (Left eye)
FID 114657 or OPTIVE
|
artificial tears
artificial tears
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
February 2, 2012
Last Update Submitted That Met QC Criteria
February 1, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-07-61
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.