Clinical Evaluation of Systane® Balance in Dry Eye Subjects

NCT02511379 | Terminated Results

• 2 other identifiers: EXJ821-P001 (C-13-039)CTRI/2015/10/006320
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corneal Staining Total Score

  The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

  Baseline (Day 0), Day 45, Day 90

Study Arms (1)

Systane Balance

EXPERIMENTAL

Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

Other: Propylene Glycol 0.6% eye drops

Interventions

Propylene Glycol 0.6% eye drops OTHER

Also known as: Systane® Balance

Systane Balance

Eligibility Criteria

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

You may qualify if:

• Sign informed consent and willing and able to attend all study visits;
• Dry eye in both eyes diagnosed by an ophthalmologist;

You may not qualify if:

• Women of childbearing potential who are pregnant or breastfeeding;
• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
• Ocular surgery 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;
• Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
• Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Study Director Med Affairs
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Research, Ltd

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: July 28, 2015
• First Posted: July 30, 2015
• Study Start: November 26, 2015
• Primary Completion: June 20, 2016
• Study Completion: June 20, 2016
• Last Updated: October 31, 2018
• Results First Posted: September 5, 2018

Record last verified: 2018-10