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

July 9, 2015 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systane Ultra
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Other: Preservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
Other: Systane® ULTRA lubricant eyedrops
Active Comparator: Optive
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Other: Preservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
Other: OPTIVE® lubricating eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 35
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.
Day 35
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.
Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Steve Burmaster, Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-12-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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