A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
NCT ID: NCT03533244
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2018-10-11
2019-10-25
Brief Summary
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Hypothesis
1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
Interventions
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0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
Eligibility Criteria
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Inclusion Criteria
* Females of childbearing potential must have a negative pregnancy test at baseline and must be on established, adequate contraception and males must use condoms if their partner is of childbearing potential and their female partner should also use an additional effective means of contraception, or they must agree to abstain from sexual intercourse with a female partner for the duration of the study; contraception should be continued for 3 months after the last dose.
* Presence of pterygium with associated conjunctival hyperemia (redness) of grade ≥2 as assessed by a central reading center.
Exclusion Criteria
* Diagnosis of ocular hypertension or glaucoma requiring use of intraocular pressure-lowering medication
* Use of contact lenses during the study in the study eye
* History or evidence of ocular surgeries in the study eye at any time
* History of liver dysfunction or current abnormal liver enzymes
* Pregnancy, plans for pregnancy, or breastfeeding during the study
18 Years
ALL
No
Sponsors
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Allgenesis Biotherapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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M.T. Coroneo Pty Ltd
Randwick, New South Wales, Australia
H2Vision Centre
Sippy Downs, Queensland, Australia
Bendigo Eye Clinic
Bendigo, Victoria, Australia
Essendon Eye Clinic
Essendon, Victoria, Australia
The Geelong Eye Centre
Waurn Ponds, Victoria, Australia
Lions Eye Institute
Nedlands, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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P2-86893-001
Identifier Type: -
Identifier Source: org_study_id