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OpenTrials
Completed

NCT Number: NCT01863368

Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Completed

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing and able to attend all study visits.
  • Diagnosis of dry eye, as specified in protocol.
  • Uses artificial tears, as specified in protocol.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Poor visual acuity, as specified in protocol.
  • Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
  • Any hypersensitivity or allergy to the investigational products or ingredients.
  • Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
  • Contact lens use within 2 weeks of Screening Visit.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Preservative-free saline solution eyedrops

Other

1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

Systane® ULTRA lubricant eyedrops

Other

OPTIVE® lubricating eyedrops

Other

Primary outcomes

  1. Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)

    Time frame: Baseline, Day 35

    The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)

    Time frame: Day 35

    The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.

  2. Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)

    Time frame: Day 35

    The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.

  3. Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)

    Time frame: Day 35

    The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 27, 2013
Registry last updated
Aug 4, 2015

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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