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Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

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: NCT02815293
Recruitment Status : Terminated
First Posted : June 28, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:

The objectives of this study are twofold

  • To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE)
  • To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: AGN-195263 Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Arm Intervention/treatment
Experimental: AGN-195263 Drug: AGN-195263
1 drop of AGN-195263 will be instilled in each eye twice daily.

Placebo Comparator: Vehicle Drug: Vehicle
1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.




Primary Outcome Measures :
  1. Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) [ Time Frame: 6 month visit ]
    The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.


Secondary Outcome Measures :
  1. Change From Baseline in Tearfilm Break Up Time (TBUT) [ Time Frame: Baseline (day 1) to 6 month visit ]
    For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for analysis



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:

  • Male, 18 years of age or older, at the screening (day -51) visit OR
  • Females, who are naturally postmenopausal (permanent cessation of menstrual periods for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal occlusion, hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at the screening (day -51) visit
  • In at least 1 eye, all of the following objective measures of evaporative dry eye (EDE) must be present at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits

    • Tear film break-up time (TBUT) ≥ 2 seconds and ≤ 7 seconds
    • Corneal sodium fluorescein staining score ≥ 1 and ≤ 4 (Oxford scheme)
    • Anesthetized Schirmer's tear test score ≥ 10 mm after 5 minutes
  • At the standardization (day -21) and baseline (day 1) visits, patients must have:

    • Ocular Surface Disease Index© (OSDI) score > 12 (0 to 100 scale)
    • Overall ocular discomfort score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
    • Ocular burning score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
    • Blurred vision score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
  • In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
  • In at least 1 eye, the number of lower lid margin expressible meibomian glands must be ≥ 3 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
  • Use of an artificial tear product or lid hygiene (ie, warm compress, lid massage, lid scrub) for the treatment of dry eye disease, EDE or meibomian gland disease within 1 year of the standardization (day -21) visit

Exclusion Criteria:

  • Male patients with a history of, known, or suspected prostate cancer
  • Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L
  • Female patients with a history of known or suspected breast, cervical, ovarian, or uterine cancer
  • Female patient who is of child-bearing potential
  • At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin meibum quality global assessment score of non-expressible (NE) in either eye
  • Patients who are currently or have used hormone replacement therapy or estrogen and /or progesterone based products (including herbal and nutritional supplements) within 90 days of the standardization (day -21) visit or anticipated use during the study
  • Patients who are currently using or have used any androgen or anti-androgen treatment (including herbal and nutritional supplements), within 90 days of the standardization (day -21) visit or anticipated use during the study
  • Patients who are currently using or have used any hair growth product within 90 days of the standardization (day -21) visit or anticipated use during the study
  • Patients who are currently using or have used corticosteroids administered via any route within 30 days prior to the standardization (day -21) visit, or any anticipated use via any route of administration prior to the month 6 visit
  • Patients who are currently using or have used oral or topical macrolides, tetracycline, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), or calcineurin inhibitors (ie, RESTASIS®, Ikervis®) within 60 days of the standardization (day -21) visit, or anticipated use prior to the month 6 visit

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): NCT02815293


Locations
Show Show 29 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02815293    
Other Study ID Numbers: 195263-009
First Posted: June 28, 2016    Key Record Dates
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019
Last Verified: February 2019
Keywords provided by Allergan:
EDE
evaporative dry eye
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