N/A
N=200
Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT02380248 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in Corneal Staining at All Study Time Points — -2.7; -4.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Corneal Staining at All Study Time Points |
-2.7; -4.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02380248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.