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Completed

NCT Number: NCT02280473

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

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

North Bay Eye Associates, Petaluma, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Refresh Optive® Gel Drops

Drug

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

REFRESH LIQUIGEL®

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Apr 16, 2019

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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