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Trial record 1 of 1 for:    SHP640-303
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Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

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ClinicalTrials.gov Identifier: NCT03004924
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
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 Bacterial Conjunctivitis
Interventions Drug: SHP640
Drug: PVP-I 0.6%
Drug: Placebo
Enrollment 753
Recruitment Details Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).
Pre-assignment Details A total of 1080 participants were screened, of them 753 enrolled and randomized to treatment. One participant was randomized in error and therefore captured only in the intent-to-treat (ITT) population.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days. Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days. Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Period Title: Overall Study
Started 324 108 321
Completed 297 94 293
Not Completed 27 14 28
Reason Not Completed
Adverse Event             6             5             10
Protocol Violation             4             0             1
Withdrawal by Subject             5             3             5
Lost to Follow-up             6             1             4
Lack of Efficacy             2             4             2
Physician Decision             1             0             1
Withdrawal by parent/guardian             1             0             2
Screen Failure             1             0             0
Pregnancy             0             1             0
Terminated by Sponsor             0             0             1
Missed Study Visit             0             0             2
HSV1 Positive             1             0             0
Arm/Group Title SHP640 PVP-I 0.6% Placebo Total
Hide Arm/Group Description Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days. Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days. Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 324 108 321 753
Hide Baseline Analysis Population Description
ITT population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 324 participants 108 participants 321 participants 753 participants
44.2  (22.87) 43.1  (23.03) 44.7  (23.00) 44.3  (22.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 324 participants 108 participants 321 participants 753 participants
Female
191
  59.0%
71
  65.7%
199
  62.0%
461
  61.2%
Male
133
  41.0%
37
  34.3%
122
  38.0%
292
  38.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 324 participants 108 participants 321 participants 753 participants
Hispanic or Latino
62
  19.1%
30
  27.8%
87
  27.1%
179
  23.8%
Not Hispanic or Latino
254
  78.4%
76
  70.4%
230
  71.7%
560
  74.4%
Not reported
4
   1.2%
2
   1.9%
2
   0.6%
8
   1.1%
Other
4
   1.2%
0
   0.0%
2
   0.6%
6
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 324 participants 108 participants 321 participants 753 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
3
   0.9%
4
   0.5%
Asian
12
   3.7%
0
   0.0%
8
   2.5%
20
   2.7%
Black or African American
54
  16.7%
18
  16.7%
54
  16.8%
126
  16.7%
White
250
  77.2%
88
  81.5%
250
  77.9%
588
  78.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
2
   0.6%
2
   0.3%
Other
6
   1.9%
1
   0.9%
4
   1.2%
11
   1.5%
Multiple
2
   0.6%
0
   0.0%
0
   0.0%
2
   0.3%
1.Primary Outcome
Title Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Hide Description Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 220 0 222
Measure Type: Count of Participants
Unit of Measure: Participants
111
  50.5%
0
95
  42.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SHP640, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
-1.6 to 16.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Hide Description Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time Frame Baseline, Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 217 0 218
Measure Type: Count of Participants
Unit of Measure: Participants
94
  43.3%
0
102
  46.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SHP640, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-12.8 to 5.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Clinical Resolution
Hide Description Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame Day 3, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3 Number Analyzed 215 participants 76 participants 218 participants
39
  18.1%
6
   7.9%
39
  17.9%
Day 8 Number Analyzed 205 participants 65 participants 206 participants
148
  72.2%
39
  60.0%
133
  64.6%
Day 12 Number Analyzed 195 participants 62 participants 187 participants
150
  76.9%
47
  75.8%
154
  82.4%
4.Secondary Outcome
Title Number of Participants With Bacterial Eradication
Hide Description Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
Time Frame Day 3, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3 Number Analyzed 213 participants 75 participants 214 participants
76
  35.7%
33
  44.0%
79
  36.9%
Day 8 Number Analyzed 205 participants 64 participants 200 participants
85
  41.5%
25
  39.1%
87
  43.5%
Day 12 Number Analyzed 194 participants 60 participants 183 participants
83
  42.8%
21
  35.0%
82
  44.8%
5.Secondary Outcome
Title Bulbar Conjunctival Injection Score
Hide Description Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time Frame Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 216 participants 76 participants 218 participants
1.0  (0.84) 1.3  (0.90) 1.1  (0.86)
Day 5 Number Analyzed 207 participants 65 participants 209 participants
0.5  (0.77) 0.7  (0.88) 0.7  (0.80)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
0.3  (0.64) 0.4  (0.61) 0.4  (0.61)
Day 12 Number Analyzed 196 participants 62 participants 187 participants
0.2  (0.56) 0.2  (0.47) 0.2  (0.48)
6.Secondary Outcome
Title Change From Baseline in the Bulbar Conjunctival Injection Score
Hide Description Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time Frame Baseline, Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 216 participants 76 participants 218 participants
-1.0  (0.77) -0.8  (0.76) -0.9  (0.76)
Day 5 Number Analyzed 207 participants 65 participants 209 participants
-1.5  (0.87) -1.3  (0.99) -1.3  (0.85)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
-1.8  (0.91) -1.6  (0.86) -1.6  (0.81)
Day 12 Number Analyzed 196 participants 62 participants 187 participants
-1.8  (0.89) -1.8  (0.74) -1.8  (0.82)
7.Secondary Outcome
Title Ocular Conjunctival Discharge Score
Hide Description Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 215 participants 76 participants 218 participants
0.7  (0.73) 0.8  (0.74) 0.7  (0.76)
Day 5 Number Analyzed 206 participants 65 participants 209 participants
0.3  (0.57) 0.2  (0.44) 0.4  (0.60)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
0.1  (0.43) 0.1  (0.31) 0.2  (0.47)
Day 12 Number Analyzed 195 participants 62 participants 187 participants
0.1  (0.49) 0.0  (0.22) 0.1  (0.28)
8.Secondary Outcome
Title Change From Baseline in the Ocular Conjunctival Discharge Score
Hide Description Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame Baseline, Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 215 participants 76 participants 218 participants
-0.9  (0.77) -0.8  (0.67) -0.9  (0.85)
Day 5 Number Analyzed 206 participants 65 participants 209 participants
-1.4  (0.74) -1.4  (0.75) -1.3  (0.75)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
-1.5  (0.71) -1.5  (0.73) -1.4  (0.74)
Day 12 Number Analyzed 195 participants 62 participants 187 participants
-1.5  (0.76) -1.6  (0.71) -1.6  (0.73)
9.Secondary Outcome
Title Global Clinical Score
Hide Description Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 215 participants 76 participants 218 participants
1.7  (1.37) 2.1  (1.39) 1.9  (1.42)
Day 5 Number Analyzed 206 participants 65 participants 209 participants
0.8  (1.18) 0.9  (1.19) 1.0  (1.18)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
0.4  (0.93) 0.5  (0.77) 0.6  (0.93)
Day 12 Number Analyzed 195 participants 62 participants 187 participants
0.4  (0.90) 0.3  (0.55) 0.3  (0.67)
10.Secondary Outcome
Title Change From Baseline in the Global Clinical Score
Hide Description Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame Baseline, Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 3 Number Analyzed 215 participants 76 participants 218 participants
-1.9  (1.28) -1.6  (1.22) -1.8  (1.30)
Day 5 Number Analyzed 206 participants 65 participants 209 participants
-2.9  (1.27) -2.8  (1.47) -2.6  (1.31)
Day 8 Number Analyzed 205 participants 65 participants 206 participants
-3.2  (1.36) -3.2  (1.25) -3.1  (1.25)
Day 12 Number Analyzed 195 participants 62 participants 187 participants
-3.3  (1.38) -3.4  (1.06) -3.3  (1.23)
11.Secondary Outcome
Title Number of Participants With Modified Clinical Resolution
Hide Description Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3 Number Analyzed 215 participants 76 participants 218 participants
100
  46.5%
28
  36.8%
93
  42.7%
Day 5 Number Analyzed 206 participants 65 participants 209 participants
166
  80.6%
48
  73.8%
143
  68.4%
Day 8 Number Analyzed 205 participants 65 participants 206 participants
189
  92.2%
59
  90.8%
175
  85.0%
Day 12 Number Analyzed 195 participants 62 participants 187 participants
182
  93.3%
59
  95.2%
173
  92.5%
12.Secondary Outcome
Title Number of Participants With Expanded Clinical Resolution
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. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame Day 3, 5, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 226 76 227
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3 Number Analyzed 215 participants 76 participants 218 participants
155
  72.1%
46
  60.5%
154
  70.6%
Day 5 Number Analyzed 206 participants 65 participants 209 participants
185
  89.8%
54
  83.1%
171
  81.8%
Day 8 Number Analyzed 205 participants 65 participants 206 participants
193
  94.1%
63
  96.9%
192
  93.2%
Day 12 Number Analyzed 195 participants 62 participants 187 participants
185
  94.9%
61
  98.4%
181
  96.8%
13.Secondary Outcome
Title Time to Clinical Resolution
Hide Description Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
Time Frame Baseline to Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Median (95% Confidence Interval)
Unit of Measure: Days
5
(5.0 to 8.0)
6
(5.0 to 8.0)
8
(5.0 to 8.0)
14.Secondary Outcome
Title Number of Participants Who Used Rescue Medication
Hide Description Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
Time Frame Baseline to Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 223 76 227
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
3
   3.9%
4
   1.8%
15.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description 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. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
Time Frame From start of study drug administration up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of investigational product.
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description:
Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
Overall Number of Participants Analyzed 323 108 321
Measure Type: Count of Participants
Unit of Measure: Participants
106
  32.8%
43
  39.8%
61
  19.0%
Time Frame From start of study drug administration up to 14 days.
Adverse Event Reporting Description One participant was randomized in error and therefore captured in the ITT population, but not in the Safety Population.
 
Arm/Group Title SHP640 PVP-I 0.6% Placebo
Hide Arm/Group Description Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days. Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days. Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
All-Cause Mortality
SHP640 PVP-I 0.6% Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/323 (0.00%)      0/108 (0.00%)      0/321 (0.00%)    
Hide Serious Adverse Events
SHP640 PVP-I 0.6% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/323 (0.00%)      0/108 (0.00%)      0/321 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SHP640 PVP-I 0.6% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/323 (20.74%)      26/108 (24.07%)      7/321 (2.18%)    
General disorders       
Instillation site pain * 1  67/323 (20.74%)  68 26/108 (24.07%)  26 7/321 (2.18%)  7
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
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@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03004924    
Other Study ID Numbers: SHP640-303
2016-003361-25 ( EudraCT Number )
First Submitted: December 19, 2016
First Posted: December 29, 2016
Results First Submitted: September 24, 2019
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019