The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
Percentage of Participants With Clinical Resolution on Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.
Time frame: Day 6
Percentage of Participants With Adenoviral Eradication on Day 6
Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.
Time frame: Day 6
Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8
Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 6 and 8
Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)
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Lugene Eye Institute Inc
Glendale, California, United States
University of Southern California
Los Angeles, California, United States
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Danbury Eye Physicians and Surgeons
Danbury, Connecticut, United States
Bruce A. Segal, MD, PA
Delray Beach, Florida, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
South Florida Research Center Inc.
Miami, Florida, United States
International Research Center
Tampa, Florida, United States
Saltzer Medical Group
Nampa, Idaho, United States
...and 21 more locations
Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.
Time frame: Day 3, 8 and 12/ET
Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.
Time frame: Day 3, 8 and 12/ET
Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 3, 6, 8 and 12/ET
Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 3, 6, 8 and 12/ET
Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 3, 6, 8 and 12/ET
Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)
Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.
Time frame: Day 3, 6, 8 and 12/ET
Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.
Time frame: From start of study drug administration up to Day 13