A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
Condition: Pterygium
MeSH terms: Pterygium
Intervention: 0.1% AG-86893 Eye Drops; 0.3% AG-86893 Eye Drops; Vehicle Eye Drops
Intervention description: One drop, three times daily to the study eye for 28 days; One drop, three times daily to the study eye for 28 days; One drop, three times daily to the study eye for 28 days
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperemia

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

        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
    

Eligibility 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