Tear Film Break-Up Time Evaluation of FID 114657
November 17, 2016 updated by: Alcon Research
To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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:
- The 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 at Visit 1 (Screening): Patients' 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 <5 seconds in at least one eye; > Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
- Able and willing to follow study instructions.
- Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
- Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.
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 of intolerance or hypersensitivity to any component of the study medications.
- 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.
- 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 Visit 1. In addition, the dosing regimen must remain stable throughout the study.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.
- Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
- Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.
- 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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Period 1
FID 114657 or SootheXP
|
artificial tears
artificial tears
|
|
Other: Period 2
FID 114657 or SootheXP
|
artificial tears
artificial tears
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
tear film break-up time (TFBUT)
Time Frame: Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 120 minutes post instillation.
|
Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 120 minutes post instillation.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Acute comfort
Time Frame: Immediately post instillation of test article
|
Immediately post instillation of test article
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 17, 2016
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-09-030
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.