Trial Outcomes & Findings for Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo (NCT NCT02998541)
NCT ID: NCT02998541
Last Updated: 2021-06-14
Results Overview
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. 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 represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
TERMINATED
PHASE3
219 participants
Day 6
2021-06-14
Participant Flow
This study was conducted at 97 sites in 15 countries between 27 March 2017 (first participant enrolled) to 13 May 2019 (last participant completed).
A total of 219 participants were randomized and 196 completed the study. Among which 219 were included in intent-to-treat (ITT) population, 217 in safety population, 83 in modified intent-to treat (mITT) population. Two participants were included in ITT population but not in safety population.
Participant milestones
| Measure |
SHP640
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
90
|
43
|
|
Overall Study
COMPLETED
|
78
|
81
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
6
|
Reasons for withdrawal
| Measure |
SHP640
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
0
|
1
|
Baseline Characteristics
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
Baseline characteristics by cohort
| Measure |
SHP640
n=86 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=90 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=43 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 19.56 • n=5 Participants
|
42.7 Years
STANDARD_DEVIATION 21.43 • n=7 Participants
|
43.4 Years
STANDARD_DEVIATION 23.67 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 21.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 6Population: Modified Intent to Treat (mITT) population consisted of a subset of the ITT population who received at least one dose of investigational product (IP) and had 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 specified time point.
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. 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 represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Outcome measures
| Measure |
SHP640
n=32 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=14 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 specified time point.
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. 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 represent worse symptoms for both scores. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
Outcome measures
| Measure |
SHP640
n=32 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=28 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 specified time point.
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. 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 represent worse symptoms for both scores. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
Outcome measures
| Measure |
SHP640
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=28 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=14 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 specified time point.
Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (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 participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
Outcome measures
| Measure |
SHP640
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=27 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=15 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
|
0 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 specified time point.
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 at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Outcome measures
| Measure |
SHP640
n=30 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=14 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
|
14 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 specified time point.
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 participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
Outcome measures
| Measure |
SHP640
n=30 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=28 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
|
14 Participants
|
20 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 6 and 8Population: 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.
qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8 and 12/ETPopulation: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 categories.
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 participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Outcome measures
| Measure |
SHP640
n=36 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=32 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=15 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
Day 8
|
20 Participants
|
22 Participants
|
13 Participants
|
|
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
Day 12/ET
|
28 Participants
|
28 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 3, 8 and 12/ETPopulation: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 categories.
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. 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 represent worse symptoms for both scores.
Outcome measures
| Measure |
SHP640
n=36 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=32 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=15 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
Day 8
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
Day 12/ET
|
20 Participants
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: 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.
The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: mITT population consisted of a subset of the ITT population who received at least one dose of IP and had 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 categories.
Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Outcome measures
| Measure |
SHP640
n=36 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=32 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=15 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Day 3
|
15 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Day 6
|
22 Participants
|
20 Participants
|
11 Participants
|
|
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Day 8
|
24 Participants
|
23 Participants
|
13 Participants
|
|
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Day 12/ET
|
30 Participants
|
27 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: 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.
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: 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.
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. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: 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.
Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3, 6, 8 and 12/ETPopulation: 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.
Time to clinical resolution were reported based on the assessments in the study eye.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of the study up to Day 14Population: Safety Population consisted of all participants who received at least one dose of IP.
An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.
Outcome measures
| Measure |
SHP640
n=86 Participants
Participants administered one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=90 Participants
Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
|
Placebo
n=41 Participants
Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
Treatment-Emergent Adverse Events
|
23 Participants
|
28 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
Serious Adverse Event
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
SHP640
PVP-I 0.6%
Placebo
Serious adverse events
| Measure |
SHP640
n=86 participants at risk
Participants received one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=90 participants at risk
Participants received one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
|
Placebo
n=41 participants at risk
Participants received one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/86 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
|
1.1%
1/90 • Number of events 1 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
|
0.00%
0/41 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
|
Other adverse events
| Measure |
SHP640
n=86 participants at risk
Participants received one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
|
PVP-I 0.6%
n=90 participants at risk
Participants received one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
|
Placebo
n=41 participants at risk
Participants received one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
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|---|---|---|---|
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General disorders
Instillation site pain
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14.0%
12/86 • Number of events 12 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
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8.9%
8/90 • Number of events 8 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
|
2.4%
1/41 • Number of events 1 • From start of the study up to Day 14
Safety Population consisted of all participants who received at least one dose of IP.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER