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Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension 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: NCT02435914
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: AGN-223575 ophthalmic solution Drug: AGN-223575 vehicle ophthalmic solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Drug: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily

Drug: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.

Experimental: AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Drug: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily

Drug: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.

Experimental: AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Drug: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily

Drug: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.

Placebo Comparator: AGN-223575 Vehicle
1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
Drug: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

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): NCT02435914


Locations
Show Show 28 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02435914    
Other Study ID Numbers: 223575-002
First Posted: May 6, 2015    Key Record Dates
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019
Last Verified: March 2019
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
Ophthalmic Solutions
Pharmaceutical Solutions