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Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

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ClinicalTrials.gov Identifier: NCT02998554
Recruitment Status : Terminated (Sponsor decision, unrelated to safety)
First Posted : December 20, 2016
Results First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Adenoviral Conjunctivitis
Interventions Drug: SHP640
Drug: Placebo
Enrollment 156
Recruitment Details The study was conducted at 30 centers in the United States and Puerto Rico between 28 March 2017 (first participant first visit) and 16 May 2019 (last participant last visit).
Pre-assignment Details A total of 156 participants were randomized and received the treatment. Out of them, 134 participants completed the study.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Period Title: Overall Study
Started 79 77
Completed 68 66
Not Completed 11 11
Reason Not Completed
Adverse Event             8             3
Protocol deviation             1             0
Withdrawal by Subject             2             6
Lost to Follow-up             0             1
Lack of Efficacy             0             1
Arm/Group Title SHP640 Placebo Total
Hide Arm/Group Description Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 79 77 156
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population consisted of all screened participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 77 participants 156 participants
42.4  (21.57) 41.3  (21.21) 41.9  (21.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 156 participants
Female
47
  59.5%
53
  68.8%
100
  64.1%
Male
32
  40.5%
24
  31.2%
56
  35.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 156 participants
Hispanic or Latino
10
  12.7%
19
  24.7%
29
  18.6%
Not Hispanic or Latino
68
  86.1%
58
  75.3%
126
  80.8%
Unknown or Not Reported
1
   1.3%
0
   0.0%
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 156 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   0.6%
Asian
4
   5.1%
0
   0.0%
4
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  12.7%
8
  10.4%
18
  11.5%
White
64
  81.0%
68
  88.3%
132
  84.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.3%
0
   0.0%
1
   0.6%
1.Primary Outcome
Title Percentage of Participants With Clinical Resolution on Day 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: Percentage of participants
11.1 20.0
2.Secondary Outcome
Title Percentage of Participants With Adenoviral Eradication on Day 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 70.0
3.Secondary Outcome
Title Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 9 12
Measure Type: Number
Unit of Measure: Percentage of participants
Day 3 Number Analyzed 9 participants 12 participants
11.1 16.7
Day 8 Number Analyzed 7 participants 9 participants
71.4 66.7
Day 12/ET Number Analyzed 9 participants 11 participants
77.8 100
5.Secondary Outcome
Title Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 9 12
Measure Type: Number
Unit of Measure: Percentage of participants
Day 3 Number Analyzed 9 participants 12 participants
11.1 0
Day 8 Number Analyzed 7 participants 9 participants
14.3 44.4
Day 12/ET Number Analyzed 9 participants 12 participants
33.3 50.0
6.Secondary Outcome
Title Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants received 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.
Participants received 1 drop of placebo matched to SHP640 ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consisted of all screened participants who received at least one dose of investigational product.
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description:
Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 79 77
Measure Type: Count of Participants
Unit of Measure: Participants
28
  35.4%
17
  22.1%
Time Frame From start of study drug administration up to Day 13
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SHP640 Placebo
Hide Arm/Group Description Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
All-Cause Mortality
SHP640 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)      0/77 (0.00%)    
Hide Serious Adverse Events
SHP640 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      0/77 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
SHP640 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/79 (25.32%)      8/77 (10.39%)    
Eye disorders     
Conjunctivitis allergic * 1  2/79 (2.53%)  2 0/77 (0.00%)  0
Corneal infiltrates * 1  2/79 (2.53%)  2 2/77 (2.60%)  2
Dry eye * 1  6/79 (7.59%)  6 2/77 (2.60%)  2
Erythema of eyelid * 1  0/79 (0.00%)  0 2/77 (2.60%)  2
General disorders     
Instillation site pain * 1  6/79 (7.59%)  6 3/77 (3.90%)  3
Infections and infestations     
Conjunctivitis * 1  5/79 (6.33%)  6 1/77 (1.30%)  1
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@takeda.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02998554    
Other Study ID Numbers: SHP640-302
2016-002440-16 ( EudraCT Number )
First Submitted: December 16, 2016
First Posted: December 20, 2016
Results First Submitted: May 13, 2020
Results First Posted: May 29, 2020
Last Update Posted: May 29, 2020