Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
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| ClinicalTrials.gov Identifier: NCT02815293 |
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Recruitment Status :
Terminated
First Posted : June 28, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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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 |
| 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 :
- 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 :
- 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
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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
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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
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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 29 study locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
Study Documents (Full-Text)
| 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:
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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 |