Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380248
• Other study ID #: EXI639-P001 (C-13-040)
• Status: Completed
• Phase: N/A
• Start date: May 14, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: May 2017
• 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® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

Locations

Country	Name	City	State
India	Contact Alcon India for Trial Locations	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website