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N/A N=200 Treatment

Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Dry Eye

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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