This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
120
American Genomics Site 1
Newport Beach, California, United States
The Number of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
Time frame: 5 minutes post dose
Time in Minutes of AG-920 to Anesthetize the Eye
Mean time to no pain score (onset)
Time frame: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.
To Evaluate How Long One Dose of AG-920 Anesthetizes the Eye
Mean duration of anesthetic effect
Time frame: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC). Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).
Time frame: from randomization through study completion (up to 4 days following treatment)
Number of Participants With a Change in Biomicroscopy
Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured time point using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil and lens of the eye with the aid of a slit lamp.
Time frame: change from baseline through end of study at Day 5
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Mean Change in Visual Acuity
Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR). Distance visual acuity was assessed using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or equivalent chart. The subject should attempt to read each letter, line by line, left to right, beginning with line 1 at the top of the chart (20/200 line).The number of letters missed is multiplied by 0.02 and added to the baseline value to determine the logMAR visual acuity. Baseline is defined as the last line for which the subject reads at least one letter. logMAR units VA = Baseline value + (n x 0.02).
Time frame: change from baseline through end of study at Day 5