Back to resultsEvaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Systane
Optive
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Corneal Staining
Eligibility Criteria
Inclusion:
- Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
- Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
- Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.
Exclusion:
- Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or 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 Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1.
- Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
- Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
- Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
- Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
- Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Systane
Optive
Arm Description
Systane
Optive
Outcomes
Primary Outcome Measures
Tear Break-up time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724412
Brief Title
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
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
Comparison of two Dry Eye products
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Corneal Staining
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane
Arm Type
Active Comparator
Arm Description
Systane
Arm Title
Optive
Arm Type
Active Comparator
Arm Description
Optive
Intervention Type
Other
Intervention Name(s)
Systane
Intervention Description
Dry Eye relief eye drops
Intervention Type
Other
Intervention Name(s)
Optive
Intervention Description
Dry Eye relief eye drops
Primary Outcome Measure Information:
Title
Tear Break-up time
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.
Exclusion:
Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or 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 Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1.
Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
12. IPD Sharing Statement
Learn more about this trial
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
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