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Completed

NCT Number: NCT02435914

Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle 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 2

Primary location

Arizona Center for Clinical Trials, Phoenix, Arizona, 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

  • Signs and symptoms of dry eye disease
  • Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

Exclusion criteria

  • History of glaucoma, or ocular hypertension
  • Diagnosis of ocular infection
  • Use of contact lenses in the past 14 days or expected use during the study
  • Use of any topical ophthalmic medications in the past 30 days
  • Use of corticosteroids in the past 30 days.

Treatment and study plan

AGN-223575 ophthalmic solution

Drug

AGN-223575 ophthalmic solution once or twice daily

AGN-223575 vehicle ophthalmic solution

Drug

Vehicle to AGN22375 ophthalmic solution once or twice daily.

Primary outcomes

  1. Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale

    Time frame: Baseline, Day 14

    Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.

Secondary outcomes

  1. Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale

    Time frame: Baseline, Day 14

    OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement.

  2. Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale

    Time frame: Baseline, Day 14

    The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement.

  3. Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye

    Time frame: Day 14

    A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
Apr 5, 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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