Trial Outcomes & Findings for A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease (NCT NCT01212471)
NCT ID: NCT01212471
Last Updated: 2020-09-04
Results Overview
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
840 participants
Primary outcome timeframe
42 days
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
Bromfenac Ophthalmic Solution 0.06%
Bromfenac Ophthalmic Solution 0.06% twice a day
|
Bromfenac Ophthalmic Solution 0.03%
Bromfenac Ophthalmic Solution 0.03% twice a day
|
Placebo Comparator
Placebo Comparator
Placebo Comparator: sterile ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
141
|
140
|
139
|
|
Overall Study
COMPLETED
|
139
|
137
|
132
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Bromfenac Ophthalmic Solution 0.06%
n=141 Participants
Bromfenac Ophthalmic Solution 0.06% twice a day
|
Bromfenac Ophthalmic Solution 0.03%
n=140 Participants
Bromfenac Ophthalmic Solution 0.03% twice a day
|
Placebo Comparator
n=139 Participants
Placebo Comparator
Placebo Comparator: sterile ophthalmic solution
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
61.6 years
n=7 Participants
|
61.0 years
n=5 Participants
|
61.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 42 daysThe Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Outcome measures
| Measure |
Bromfenac Ophthalmic Solution 0.06%
n=141 Participants
Bromfenac Ophthalmic Solution 0.06% twice a day
|
Bromfenac Ophthalmic Solution 0.03%
n=140 Participants
Bromfenac Ophthalmic Solution 0.03% twice a day
|
Placebo Comparator
n=139 Participants
Placebo Comparator
Placebo Comparator: sterile ophthalmic solution
|
|---|---|---|---|
|
Mean Ocular Surface Disease Index (OSDI) Total Score
|
35.0 score on a scale
Standard Deviation 22.23
|
40.3 score on a scale
Standard Deviation 25.22
|
36.9 score on a scale
Standard Deviation 23.24
|
Adverse Events
Bromfenac Ophthalmic Solution 0.06%
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Bromfenac Ophthalmic Solution 0.03%
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bromfenac Ophthalmic Solution 0.06%
n=141 participants at risk
Bromfenac Ophthalmic Solution 0.06% twice a day
|
Bromfenac Ophthalmic Solution 0.03%
n=140 participants at risk
Bromfenac Ophthalmic Solution 0.03% twice a day
|
Placebo Comparator
n=139 participants at risk
Placebo Comparator
Placebo Comparator: sterile ophthalmic solution
|
|---|---|---|---|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Nervous system disorders
Cerebrovascular event
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Nervous system disorders
Dizziness
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Nervous system disorders
Syncope
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Melaena
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Nausea
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
General disorders
Adverse drug reaction
|
0.00%
0/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.72%
1/139 • 10 days
|
|
General disorders
Chest discomfort
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
General disorders
Fatigue
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
General disorders
Pyrexia
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Infections and infestations
Cellulitis
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Investigations
Liver function test abnormal
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Psychiatric disorders
Agitation
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Psychiatric disorders
Confusional state
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Psychiatric disorders
Mental status change
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/141 • 10 days
|
0.71%
1/140 • 10 days
|
0.00%
0/139 • 10 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.71%
1/141 • 10 days
|
0.00%
0/140 • 10 days
|
0.00%
0/139 • 10 days
|
Other adverse events
| Measure |
Bromfenac Ophthalmic Solution 0.06%
n=141 participants at risk
Bromfenac Ophthalmic Solution 0.06% twice a day
|
Bromfenac Ophthalmic Solution 0.03%
n=140 participants at risk
Bromfenac Ophthalmic Solution 0.03% twice a day
|
Placebo Comparator
n=139 participants at risk
Placebo Comparator
Placebo Comparator: sterile ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
6.4%
9/141 • 10 days
|
5.7%
8/140 • 10 days
|
5.0%
7/139 • 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER