Back to resultsResidence Time Evaluation of Marketed OTC Ophthalmic Products
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane Ultra Lubricant Eye Drops
Unisol 4 Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring dry eye, autofluorescence, residence time
Eligibility Criteria
Inclusion Criteria:
- Informed consent and HIPAA read, signed and dated before conducting any procedures.
- Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
- Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
Exclusion Criteria:
- History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
- History or evidence of serious ocular trauma in either eye w/i the past 6 months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
- Use of concomitant topical ocular medications during the study period.
- Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
- Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
- Participation in an investigational drug or device study w/i 30 days of entering this study.
- Additionally, any subject may be declared ineligible for a valid medical reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Systane
Unisol
Arm Description
One drop dispensed into each eye
One drop dispensed into each eye
Outcomes
Primary Outcome Measures
Ocular Surface Residence Time
Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00804791
Brief Title
Residence Time Evaluation of Marketed OTC Ophthalmic Products
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye, autofluorescence, residence time
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane
Arm Type
Active Comparator
Arm Description
One drop dispensed into each eye
Arm Title
Unisol
Arm Type
Active Comparator
Arm Description
One drop dispensed into each eye
Intervention Type
Other
Intervention Name(s)
Systane Ultra Lubricant Eye Drops
Intervention Description
artificial tears solution for lubricating the cornea
Intervention Type
Other
Intervention Name(s)
Unisol 4 Saline Solution
Intervention Description
saline solution for irrigating the cornea
Primary Outcome Measure Information:
Title
Ocular Surface Residence Time
Description
Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
Time Frame
After 8 minutes, then every 2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent and HIPAA read, signed and dated before conducting any procedures.
Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
Exclusion Criteria:
History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
History or evidence of serious ocular trauma in either eye w/i the past 6 months.
History of intolerance or hypersensitivity to any component of the study medications.
History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
Use of concomitant topical ocular medications during the study period.
Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
Participation in an investigational drug or device study w/i 30 days of entering this study.
Additionally, any subject may be declared ineligible for a valid medical reason.
12. IPD Sharing Statement
Learn more about this trial
Residence Time Evaluation of Marketed OTC Ophthalmic Products
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