Back to resultsClinical Evaluation of Systane® Balance in Dry Eye Subjects
Primary Purpose
Dry Eye
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Propylene Glycol 0.6% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Sign informed consent and willing and able to attend all study visits;
- Dry eye in both eyes diagnosed by an ophthalmologist;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential who are pregnant or breastfeeding;
- Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
- Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
- Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
- Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
- Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systane Balance
Arm Description
Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
Outcomes
Primary Outcome Measures
Change From Baseline in Corneal Staining Total Score
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02511379
Brief Title
Clinical Evaluation of Systane® Balance in Dry Eye Subjects
Official Title
Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of product development
Study Start Date
November 26, 2015 (Actual)
Primary Completion Date
June 20, 2016 (Actual)
Study Completion Date
June 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.
Detailed Description
This study was conducted in India.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Balance
Arm Type
Experimental
Arm Description
Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
Intervention Type
Other
Intervention Name(s)
Propylene Glycol 0.6% eye drops
Other Intervention Name(s)
Systane® Balance
Primary Outcome Measure Information:
Title
Change From Baseline in Corneal Staining Total Score
Description
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
Time Frame
Baseline (Day 0), Day 45, Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign informed consent and willing and able to attend all study visits;
Dry eye in both eyes diagnosed by an ophthalmologist;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential who are pregnant or breastfeeding;
Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research, Ltd
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Systane® Balance in Dry Eye Subjects
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