Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

NCT02380248 | Completed Results

• 1 other identifier: EXI639-P001 (C-13-040)
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Systane

EXPERIMENTAL

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

Interventions

Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops OTHER

Also known as: Systane® Gel Drops

Systane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon India for Trial Locations

Karnataka, 560048, India

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Polyethylene Glycols; Propylene Glycol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Propylene Glycols; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Clinical Scientific Associate Director, GCRA-GDD
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Head, CTM, Med Affairs

  Alcon Laboratories Pvt Ltd (India)

  STUDY DIRECTOR

• Sr. Clinical Manager, Global Trial Leadership

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 5, 2015
• Study Start: May 14, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 2, 2018
• Results First Posted: May 5, 2017

Record last verified: 2017-05

Locations

IN (1)