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Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia (GEMINI 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03804268
Recruitment Status : Completed
First Posted : January 15, 2019
Results First Posted : December 28, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Presbyopia
Interventions Other: Vehicle
Drug: Pilocarpine HCl Ophthalmic Solution
Enrollment 323
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description Participants received one drop of vehicle in each eye, once daily, for up to 30 days. Participants received one drop of pilocarpine hydrochloride (HCl) ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Period Title: Overall Study
Started 160 163
Completed 153 161
Not Completed 7 2
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             2             0
Lost to Follow-up             1             0
Physician Decision             2             0
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution Total
Hide Arm/Group Description Participants received one drop of vehicle in each eye, once daily, for up to 30 days. Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days. Total of all reporting groups
Overall Number of Baseline Participants 160 163 323
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants 163 participants 323 participants
49.7  (3.23) 49.5  (3.81) 49.6  (3.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 163 participants 323 participants
Female
122
  76.3%
113
  69.3%
235
  72.8%
Male
38
  23.8%
50
  30.7%
88
  27.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 163 participants 323 participants
Hispanic or Latino
26
  16.3%
31
  19.0%
57
  17.6%
Not Hispanic or Latino
134
  83.8%
132
  81.0%
266
  82.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 163 participants 323 participants
American Indian or Alaska Native
2
   1.3%
0
   0.0%
2
   0.6%
Asian
1
   0.6%
2
   1.2%
3
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
   7.5%
13
   8.0%
25
   7.7%
White
144
  90.0%
148
  90.8%
292
  90.4%
More than one race
1
   0.6%
0
   0.0%
1
   0.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Hide Description Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population included all randomized participants. Missing data was imputed as non-responders.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 160 163
Measure Type: Number
Unit of Measure: percentage of participants
8.1 30.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 22.5
Confidence Interval (2-Sided) 95%
14.3 to 30.8
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.
2.Secondary Outcome
Title Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6
Hide Description Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Time Frame Baseline (Day 1) to Day 30 (Hour 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Missing data was imputed as non-responders.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 160 163
Measure Type: Number
Unit of Measure: percentage of participants
8.8 18.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
2.3 to 17.0
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.
3.Secondary Outcome
Title Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8
Hide Description Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Time Frame Baseline (Day 1) to Day 30 (Hour 8)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 161
Measure Type: Number
Unit of Measure: percentage of participants
8.5 10.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-4.4 to 8.5
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.
4.Secondary Outcome
Title Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5
Hide Description Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. Mixed effect model for repeated measures (MMRM) was used for analyses.
Time Frame Baseline (Day 1) to Day 30 (Hour 0.5)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 158
Least Squares Mean (Standard Error)
Unit of Measure: letters read correctly
4.2  (0.55) 9.3  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.
Method MMRM
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
3.7 to 6.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1
Hide Description Visual acuity for near (40 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.
Time Frame Day 30 (Hour 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 161
Measure Type: Number
Unit of Measure: percentage of participants
73.9 92.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 18.7
Confidence Interval (2-Sided) 95%
10.6 to 26.7
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.
6.Secondary Outcome
Title Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3
Hide Description NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent;impact of squinting on performance as 0=No,I did not squint, 1=Yes,squinting helped me read some/all text, 2=Yes,but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. The score based on vision related ability and impact of squinting=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses), total possible score of 0-5. Higher scores=better outcomes;positive change from Baseline=improved performance(reading ability).
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. Analysis of Covariance (ANCOVA) was used for analysis.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 148 154
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.6  (0.11) 1.4  (0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.
Method ANCOVA
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.6 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3
Hide Description Visual acuity for intermediate (66 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 161
Least Squares Mean (Standard Error)
Unit of Measure: letters read correctly
3.1  (0.42) 6.6  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.
Method MMRM
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
2.4 to 4.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10
Hide Description Visual acuity for near (40cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported.
Time Frame Baseline (Day1) to Day 30 (Hour 10)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 152 160
Measure Type: Number
Unit of Measure: percentage of participants
8.6 7.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-7.1 to 5.0
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.
9.Secondary Outcome
Title Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25
Hide Description Visual acuity for near (40 cm) target was measured in mesopic conditions. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.
Time Frame Baseline (Day 1) to Day 30 (Hour 0.25)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 158
Least Squares Mean (Standard Error)
Unit of Measure: letters correctly read
3.7  (0.50) 6.3  (0.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.
Method MMRM
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.3 to 3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3
Hide Description Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.
Time Frame Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 153 161
Measure Type: Number
Unit of Measure: percentage of participants
71.9 84.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0171
Comments P-value was adjusted for multiplicity control.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
3.5 to 21.6
Estimation Comments Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.
11.Secondary Outcome
Title Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3
Hide Description NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close to 5=excellent; impact of squinting on performance as 0=No, I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes, but I still could not read any of the text; and satisfaction as 0=very dissatisfied,1=dissatisfied,2=neither satisfied nor dissatisfied,3=satisfied, 4=very satisfied. The score based on satisfaction items=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses) for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline=higher satisfaction.
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. ANCOVA was used for analysis.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 148 154
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.6  (0.11) 1.4  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.
Method ANCOVA
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.5 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3
Hide Description PICQ=20 questions about impact experienced by participants due to their problems over past 7 days.PICQ Coping domain had 8 items: 1:Normal-sized text,2:Small-sized text,3:Information on a computer,4:Information on a cell phone,5:Increase font size,6:Use glasses to read close,12:Hold reading materials farther out/closer,13:Squint to read. Each item had response categories:0=never to 4=all the time. Items 3, 4, 5, and 6 had additional response categories with values of 9/10 to indicate the question is not applicable to participant and were assigned missing values.PICQ Coping Score:(Item 1,2 Testlet+Item 3,4 Testlet+Item 5+Item 6+Item 12+Item 13)/non-missing responses to the 6 components of coping score where Items 1,2 Testlet=(Item1+Item2)/non-missing responses to Items 1,2;Items 3,4 Testlet=(Item3+Item4)/non-missing responses to Items 3, 4. Score ranges:0=to least amount of coping to 4=greatest amount of coping. Higher scores=poorer outcome; a negative change from Baseline=improvement.
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. ANCOVA was used for analysis.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 148 159
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.5  (0.07) -1.0  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.
Method ANCOVA
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.6 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3
Hide Description PICQ had 20 questions about impact experienced by participants due to their problems seeing up over past 7 days. PICQ Impact domain had 6 items: Item 9:Rely on others,15:rest eyes,16:Feel older,17:Feel self-conscious,19:Take longer to complete a task,20:Inconvenient. First 5 impacts items included response categories: 0=never to 4=all the time. Item 20 had response categories: 0=not at all to 4=extremely. Item 9 included an additional response category with a value of 9 to indicate question was not applicable to participant and the responses were assigned missing values. PICQ Impacts Score=[(Item9+Item15+Items16,17Testlet+Item19+Item20)/(nonmissing responses to 5 components of impacts score)] where Items 16,17 Testlet=(Item16+Item17)/non-missing responses to Items 16 and 17. PICQ Impact score ranges from 0 to 4; with 0=least amount of impacts to 4=greatest amount of impacts. Higher scores correspond to poorer outcomes. A negative change from Baseline=improvement.
Time Frame Baseline (Day 1) to Day 30 (Hour 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. ANCOVA was used for analysis.
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description:
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Overall Number of Participants Analyzed 148 159
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.4  (0.06) -0.7  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Pilocarpine HCl Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.
Method ANCOVA
Comments P-value was adjusted for multiplicity control.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Time Frame First dose of study drug intervention to within 30 days after last dose (Up to 60 days)
Adverse Event Reporting Description All-cause Mortality: All enrolled participants. Serious Adverse Events and Other (non-serious) Adverse Events: Safety Population included all participants who received at least 1 administration of study intervention.
 
Arm/Group Title Vehicle Pilocarpine HCl Ophthalmic Solution
Hide Arm/Group Description Participants received one drop of vehicle in each eye, once daily, for up to 30 days. Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
All-Cause Mortality
Vehicle Pilocarpine HCl Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/160 (0.00%)   0/163 (0.00%) 
Hide Serious Adverse Events
Vehicle Pilocarpine HCl Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/159 (0.00%)   0/163 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Pilocarpine HCl Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   15/159 (9.43%)   23/163 (14.11%) 
Nervous system disorders     
Headache  1  15/159 (9.43%)  23/163 (14.11%) 
1
Term from vocabulary, MedDRA (22.1)
Indicates events were collected by 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03804268    
Other Study ID Numbers: 1883-301-013
First Submitted: January 11, 2019
First Posted: January 15, 2019
Results First Submitted: November 27, 2021
Results First Posted: December 28, 2021
Last Update Posted: December 28, 2021