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Safety analyses were based on both eyes using the ITT population.
At the first visit, all patients underwent a 30-2 visual field examination on both eyes using the Full Threshold algorithm (Humphrey Field Analyser 750 software version A10.2).
Subjects returned approximately 15.5 h after treatment instillation (visit 3B) and were challenged 16 + 1 h after study drug instillation in both eyes using the same allergen and dose that had elicited a positive reaction at visits 1 and 2. The first study also had a fourth visit that was used to assess duration of action at 24 h post-treatment instillation.
Control subjects had a diagnosis of glaucoma suspect or ocular hypertension and had a presenting VA of better than 20/40 in both eyes, a mean deviation (MD) better than −5 decibels (dB) in both eyes using the Swedish interactive thresholding algorithm (SITA) standard Humphrey 24 2 VF test, and a glaucoma hemifield test (GHT) result other than "Outside Normal Limits" in both eyes.
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The investigator evaluated conjunctival hyperemia in both eyes using biomicroscopy and graded the severity of hyperemia using a 5-point scale with 0.5-unit increments, where 0 = none and 4 = extremely severe hyperemia (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).
Exclusion criteria included a visual acuity of worse than 0.1 logMAR, history of ocular disease such as glaucoma, and the patient being unable to complete kinetic perimetry for both eyes using both perimeters within the same testing session.
Brighten the eyes using the "Levels" tool.
Add eyes using the black beads.
At screening and at all study visits, IOP was determined in both eyes using Goldmann applanation tonometry in the sitting position.
Vitreous humor was aspirated from both eyes using a syringe.
Each solution was applied twice a day to both eyes using a compress for 4 weeks.
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