Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka, India, 560048
    • Contact Alcon India for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systane; Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days	Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops; Other Names: Systane® Gel Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0), Day 45, Day 90

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Head, CTM, Med Affairs, Alcon Laboratories Pvt Ltd (India); Study Director: Sr. Clinical Manager, Global Trial Leadership, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: EXI639-P001 (C-13-040)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No