Back to resultsClinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Must give informed consent, and be willing and able to attend all study visits.
- Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
- 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, test positive on a pregnancy test, or breast-feeding.
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
- Any contraindications or hypersensitivities to the study medications or their components.
- Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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.
- Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
- Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
- Participation in any other clinical trial within 30 days prior to Screening.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Contact Alcon India for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systane
Arm Description
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
Outcomes
Primary Outcome Measures
Change From Baseline in Corneal Staining at All Study Time Points
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02380248
Brief Title
Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
Official Title
Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 14, 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 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® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.
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
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane
Arm Type
Experimental
Arm Description
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
Intervention Type
Other
Intervention Name(s)
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops
Other Intervention Name(s)
Systane® Gel Drops
Primary Outcome Measure Information:
Title
Change From Baseline in Corneal Staining at All Study Time Points
Description
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
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:
Must give informed consent, and be willing and able to attend all study visits.
Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
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, test positive on a pregnancy test, or breast-feeding.
Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
Any contraindications or hypersensitivities to the study medications or their components.
Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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.
Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
Participation in any other clinical trial within 30 days prior to Screening.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head, CTM, Med Affairs
Organizational Affiliation
Alcon Laboratories Pvt Ltd (India)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, Global Trial Leadership
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon India for Trial Locations
City
Karnataka
ZIP/Postal Code
560048
Country
India
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
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