Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
Global Research Management
Glendale, California, United States
Foothill Eye Institute
Pasadena, California, United States
Shettle Eye Research
Largo, Florida, United States
To Evaluate the Change in Combined Clinical Score
To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe).
Time frame: Through End of Treatment (Day 8)
To Evaluate the Percent of participants requiring rescue
To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control
Time frame: Day 3
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D & H National Research Centers, INC
Miami, Florida, United States
My Community Research Center, Inc.
Miami, Florida, United States
Quantum Clinical Trials
Miami Beach, Florida, United States
Kannarr Eye Center
Pittsburg, Kansas, United States
Oculos Clinical Research
Garner, North Carolina, United States
Athens Eye Care
Athens, Ohio, United States
Revolution Research/ Lake Travis Eye and Laser Center
Lakeway, Texas, United States
...and 2 more locations