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Completed

NCT Number: NCT03533244

A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia

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

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

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Key information

Conditions

Pterygium Cardiovascular Diseases Conjunctival Diseases Eye Diseases Hyperemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M.T. Coroneo Pty Ltd, Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% AG-86893 Eye Drops

Drug

One drop, three times daily to the study eye for 28 days

0.3% AG-86893 Eye Drops

Drug

One drop, three times daily to the study eye for 28 days

Vehicle Eye Drops

Drug

One drop, three times daily to the study eye for 28 days

Primary outcomes

  1. Change From Baseline in Overall Conjunctival Hyperemia Score

    Time frame: 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 outcomes

  1. Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allgenesis Biotherapeutics Inc.

Industry

Registry information

Official study title

A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium

Acronym: SURPH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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