Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02511379
• Other study ID #: EXJ821-P001 (C-13-039)
• Secondary ID: CTRI/2015/10/006
• Status: Terminated
• Phase: N/A
• Start date: November 26, 2015
• Est. completion date: June 20, 2016

Study information

• Verified date: October 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was conducted in India.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 20, 2016
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Sign informed consent and willing and able to attend all study visits;

• 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 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;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Propylene Glycol 0.6% eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website