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A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280473
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : June 7, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Refresh Optive® Gel Drops Drug: REFRESH LIQUIGEL® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : November 13, 2014
Actual Primary Completion Date : March 16, 2015
Actual Study Completion Date : March 16, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Drug: Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Active Comparator: REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Drug: REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.




Primary Outcome Measures :
  1. Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score [ Time Frame: Baseline, Day 30 ]
    The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.


Secondary Outcome Measures :
  1. Change From Baseline in the OSDI© Score [ Time Frame: Baseline, Day 7 ]
    The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

  2. Change From Baseline in Tear Break-up Time (TBUT) [ Time Frame: Baseline, Day 30 ]
    TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.

  3. Change From Baseline in the Combined Corneal and Conjunctival Staining Scores [ Time Frame: Baseline, Day 30 ]
    The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.

  4. Change From Baseline in the Schirmer Test [ Time Frame: Baseline, Day 30 ]
    The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current use of an artificial tear product
  • Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

  • Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
  • Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
  • Current eye infection or inflammation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280473


Locations
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United States, California
North Bay Eye Associates
Petaluma, California, United States, 94954
Eric M. White, OD, Inc.
San Diego, California, United States, 92123
United States, Maine
Eye Center Northeast
Bangor, Maine, United States, 04401
United States, Missouri
Moyes Eye Center, PC
Kansas City, Missouri, United States, 64154
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090
United States, New York
Rochester Ophthalmological Group, PC
Rochester, New York, United States, 14618
United States, Rhode Island
David W. Ferris & Associates, Inc.
Warwick, Rhode Island, United States, 02888
United States, Tennessee
Primary Eyecare Group, PC
Brentwood, Tennessee, United States, 37027
The Eye Center at Southern College of Optometry
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02280473    
Other Study ID Numbers: 11193X-001
First Posted: October 31, 2014    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents