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Brief Summary:
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.
Hypothesis
- 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
- At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pterygium | Drug: 0.1% AG-86893 Eye Drops Drug: 0.3% AG-86893 Eye Drops Drug: Vehicle Eye Drops | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| ActualEnrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium |
| Actual Study Start Date : | October 11, 2018 |
| Actual Primary Completion Date : | September 5, 2019 |
| Actual Study Completion Date : | October 25, 2019 |
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| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Vehicle Eye Drops One drop, three times daily to the study eye for 28 days | Drug: Vehicle Eye Drops One drop, three times daily to the study eye for 28 days |
| Experimental: 0.1% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days | Drug: 0.1% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days |
| Experimental: 0.3% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days | Drug: 0.3% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days |
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Primary Outcome Measures :
- Change From Baseline in Overall Conjunctival Hyperemia Score [TimeFrame:Baseline and Day 28]
Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.
Secondary Outcome Measures :
- Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium [TimeFrame:Baseline and Day 28]
Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.
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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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Good health with no clinically significant findings based on the medical history, electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings, as determined by the investigator
- 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:
- History or presence of any ocular diseases other than pterygium or its sequelae (after-effects), including neoplasia (uncontrolled overgrowth)
- 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
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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): NCT03533244
Locations
| Australia, New South Wales | |
| M.T. Coroneo Pty Ltd | |
| Randwick, New South Wales, Australia | |
| Australia, Queensland | |
| H2Vision Centre | |
| Sippy Downs, Queensland, Australia | |
| Australia, Victoria | |
| Bendigo Eye Clinic | |
| Bendigo, Victoria, Australia | |
| Essendon Eye Clinic | |
| Essendon, Victoria, Australia | |
| The Geelong Eye Centre | |
| Waurn Ponds, Victoria, Australia | |
| Australia, Western Australia | |
| Lions Eye Institute | |
| Nedlands, Western Australia, Australia | |
Sponsors and Collaborators
Allgenesis Biotherapeutics Inc.
Study Documents (Full-Text)
Documents provided by Allgenesis Biotherapeutics Inc.:
Statistical Analysis Plan [PDF] November 5, 2019
Study Protocol [PDF] March 20, 2019
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| Responsible Party: | Allgenesis Biotherapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT03533244 |
| Other Study ID Numbers: | P2-86893-001 |
| First Posted: | May 23, 2018 Key Record Dates |
| Results First Posted: | November 6, 2020 |
| Last Update Posted: | November 6, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Allgenesis Biotherapeutics Inc.:
| Hyperemia |
Additional relevant MeSH terms:
| Pterygium Conjunctival Diseases Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |
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