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NCT02380248

Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Completed NA Results posted Last updated 2 July 2018
What this trial tests

NA trial testing Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops in Dry Eye in 207 participants. Completed in 1 June 2016.

Timeline
14 May 2015
Primary endpoint
1 June 2016
1 June 2016

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment207
Start date14 May 2015
Primary completion1 June 2016
Estimated completion1 June 2016
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Alcon Research — full company profile →

Who can join

Adults 18 to 65, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Corneal Staining at All Study Time Points Primary · Baseline (Day 0), Day 45, Day 90

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.

Change from baseline at Day 45
GroupValue95% CI
Systane-2.7± 0.14
Change from baseline at Day 90
GroupValue95% CI
Systane-4.0± 0.16

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Dry Eye

Currently open trials in the same condition.

Other Alcon Research trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02380248.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing