Trial Outcomes & Findings for Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose (NCT NCT02017327)
NCT ID: NCT02017327
Last Updated: 2020-04-02
Results Overview
The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit. The conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia. The Rows represent the number of participants with a change from Baseline to D84 corresponding to * "decrease of 3 points" * "decrease of 2 points" * "no change", * "increase of 2 points" * "increase of 1 point" on Mc Monnies scale
COMPLETED
PHASE4
379 participants
Day 84
2020-04-02
Participant Flow
patients were enrolled at medical clinics from Dec 2013 to July 2016
the number of patients enrolled in 379 but as the primary Endpoint is Safety, the Baseline population is based on the safety Set and it corresponds to 373 patients
Participant milestones
| Measure |
Monoprost
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
|
Lumigan 0.01% (Bimatoprost Eye Drop Solution)
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
3-mL multidose containers
|
Lumigan 0.03% UD (Bimatoprost Eye Drop Solution)
one drop in each eye once daily at 9.00 pm (± 1 hour) in the inferior conjunctival cul-de-sac from D0 to D84.
0.4-mL single-use low density polyethylene (LDPE) containers.
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
125
|
132
|
|
Overall Study
COMPLETED
|
106
|
113
|
117
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
Baseline characteristics by cohort
| Measure |
Monoprost
n=119 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
|
Lumigan 0.01%
n=124 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
|
Lumigan 0.03% Unit Dose
n=130 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
|
Total
n=373 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
138 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
235 Participants
n=483 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
68.3 years
STANDARD_DEVIATION 10 • n=27 Participants
|
67.7 years
STANDARD_DEVIATION 10.1 • n=483 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
218 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
155 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
24 participants
n=93 Participants
|
25 participants
n=4 Participants
|
26 participants
n=27 Participants
|
75 participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=93 Participants
|
12 participants
n=4 Participants
|
15 participants
n=27 Participants
|
41 participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
50 participants
n=93 Participants
|
52 participants
n=4 Participants
|
51 participants
n=27 Participants
|
153 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=93 Participants
|
24 participants
n=4 Participants
|
26 participants
n=27 Participants
|
71 participants
n=483 Participants
|
|
Region of Enrollment
Greece
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
12 participants
n=27 Participants
|
33 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: the primary analysis was performed in the mSAF.(All randomised patients of the Safety set with at least one eligible eye and with any safety information on treatment.)
The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit. The conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia. The Rows represent the number of participants with a change from Baseline to D84 corresponding to * "decrease of 3 points" * "decrease of 2 points" * "no change", * "increase of 2 points" * "increase of 1 point" on Mc Monnies scale
Outcome measures
| Measure |
Monoprost
n=112 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
|
Lumigan 0.01%
n=118 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
|
Lumigan 0.03% Unit Dose
n=124 Participants
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
|
|---|---|---|---|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 -3
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 - 2
|
29 Participants
|
13 Participants
|
19 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 -1
|
47 Participants
|
59 Participants
|
42 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 0
|
29 Participants
|
39 Participants
|
38 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 +1
|
2 Participants
|
6 Participants
|
17 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
change at D84 +2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
missing data
|
1 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Monoprost
Lumigan 0.01%
Lumigan 0.03% Unit Dose
Serious adverse events
| Measure |
Monoprost
n=119 participants at risk
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
|
Lumigan 0.01%
n=124 participants at risk
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
|
Lumigan 0.03% Unit Dose
n=130 participants at risk
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
intervetebral disk protrusion
|
0.84%
1/119 • Number of events 1 • 3 months
|
0.00%
0/124 • 3 months
|
0.00%
0/130 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.84%
1/119 • Number of events 1 • 3 months
|
0.00%
0/124 • 3 months
|
0.00%
0/130 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast neoplasm
|
0.84%
1/119 • Number of events 1 • 3 months
|
0.00%
0/124 • 3 months
|
0.00%
0/130 • 3 months
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/119 • 3 months
|
0.81%
1/124 • Number of events 1 • 3 months
|
0.00%
0/130 • 3 months
|
|
Vascular disorders
hypotension
|
0.00%
0/119 • 3 months
|
0.81%
1/124 • Number of events 1 • 3 months
|
0.00%
0/130 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic colon cancer
|
0.00%
0/119 • 3 months
|
0.00%
0/124 • 3 months
|
0.77%
1/130 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
ureterolithiasis
|
0.00%
0/119 • 3 months
|
0.00%
0/124 • 3 months
|
0.77%
1/130 • Number of events 1 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
- Publication restrictions are in place
Restriction type: OTHER