Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo
- Registration Number
- NCT02998554
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days. SHP640 SHP640 Participants instructed to instill 1 drop of SHP640 (Povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinical Resolution on Day 6 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET) Day 3, 8 and 12/ET 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.
Percentage of Participants With Adenoviral Eradication on Day 6 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.
Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8 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.
Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET) Day 3, 8 and 12/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.
Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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.
Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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.
Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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.
Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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.
Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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 to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET) Day 3, 6, 8 and 12/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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From start of study drug administration up to Day 13 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.
Trial Locations
- Locations (31)
Lugene Eye Institute Inc
🇺🇸Glendale, 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
Shettle Eye Research, Inc.
🇺🇸Largo, Florida, United States
Bowden Eye & Associates
🇺🇸Jacksonville, Florida, United States
South Florida Research Center Inc.
🇺🇸Miami, Florida, United States
International Research Center
🇺🇸Tampa, Florida, United States
Physicians to Children & Adolescents
🇺🇸Bardstown, Kentucky, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Shire Call Center
🇺🇸Lexington, Massachusetts, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Fichte, Endl and Elmer Eyecare
🇺🇸Niagara Falls, New York, United States
Cleveland Eye Clinic
🇺🇸Cleveland, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Eyeland Vision
🇺🇸El Paso, Texas, United States
Sun Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Piedmont Eye Center, Inc.
🇺🇸Lynchburg, Virginia, United States
University Of Puerto Rico, School of Medicine
🇵🇷Carolina, Puerto Rico
University of Southern California
🇺🇸Los Angeles, California, United States
Sabates Eye Centers
🇺🇸Leawood, Kansas, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Saltzer Medical Group
🇺🇸Nampa, Idaho, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
Emanuelli Research & Development Center, LLC
🇵🇷Arecibo, Puerto Rico
Apex Eye Kenwood
🇺🇸Cincinnati, Ohio, United States