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OpenTrials
Completed

NCT Number: NCT02380248

Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon India for Trial Locations

Karnataka, 560048, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Other names: Systane® Gel Drops

Primary outcomes

  1. Change From Baseline in Corneal Staining at All Study Time Points

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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