Back to resultsClinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preservative-free saline solution eyedrops
Systane® ULTRA lubricant eyedrops
OPTIVE® lubricating eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, Eye drops
Eligibility Criteria
Inclusion Criteria:
- Willing and able to attend all study visits.
- Diagnosis of dry eye, as specified in protocol.
- Uses artificial tears, as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Poor visual acuity, as specified in protocol.
- Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- Any hypersensitivity or allergy to the investigational products or ingredients.
- Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- Contact lens use within 2 weeks of Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systane Ultra
Optive
Arm Description
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Secondary Outcome Measures
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863368
Brief Title
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Official Title
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (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
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Detailed Description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, Eye drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Ultra
Arm Type
Experimental
Arm Description
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Arm Title
Optive
Arm Type
Active Comparator
Arm Description
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Intervention Type
Other
Intervention Name(s)
Preservative-free saline solution eyedrops
Intervention Description
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
Intervention Type
Other
Intervention Name(s)
Systane® ULTRA lubricant eyedrops
Intervention Type
Other
Intervention Name(s)
OPTIVE® lubricating eyedrops
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
Description
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Day 35
Secondary Outcome Measure Information:
Title
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
Description
The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.
Time Frame
Day 35
Title
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
Description
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Time Frame
Day 35
Title
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
Description
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Time Frame
Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to attend all study visits.
Diagnosis of dry eye, as specified in protocol.
Uses artificial tears, as specified in protocol.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Poor visual acuity, as specified in protocol.
Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
Any hypersensitivity or allergy to the investigational products or ingredients.
Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
Contact lens use within 2 weeks of Screening Visit.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Burmaster
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27422973
Citation
Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.
Results Reference
derived
Learn more about this trial
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
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