Trial Outcomes & Findings for Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT02796560)
NCT ID: NCT02796560
Last Updated: 2020-12-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
After 3 weeks of either the brand name or generic travoprost
Results posted on
2020-12-01
Participant Flow
Participant milestones
| Measure |
Brand Name Travoprost First, Then Generic
Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
Generic Travoprost First, Then Brand Name
Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Brand Name Travoprost First, Then Generic
Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
Generic Travoprost First, Then Brand Name
Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Brand Name Travoprost First, Then Generic
n=34 Participants
Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
Generic Travoprost First, Then Brand Name
n=36 Participants
Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.32 years
STANDARD_DEVIATION 13.22 • n=93 Participants
|
68.53 years
STANDARD_DEVIATION 11.22 • n=4 Participants
|
67.50 years
STANDARD_DEVIATION 12.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=93 Participants
|
36 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Baseline intraocular pressure
|
26.25 mm Hg
n=93 Participants
|
23.50 mm Hg
n=4 Participants
|
24.50 mm Hg
n=27 Participants
|
|
Mean deviation on visual field testing
|
-1.12 decibels
n=93 Participants
|
-2.05 decibels
n=4 Participants
|
-1.66 decibels
n=27 Participants
|
|
Number of Treatment Naive Participants
|
28 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Diagnosis
Primary open angle glaucoma
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Diagnosis
Ocular hypertension
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Diagnosis
Normal tension glaucoma
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: After 3 weeks of either the brand name or generic travoprostPopulation: There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms.
Outcome measures
| Measure |
Brand Name Travoprost
n=70 Participants
Participants who received Brand Name Travoprost one drop once daily in either the first or last 3 weeks of the study.
|
Generic Travoprost
n=70 Participants
Participants who received Generic Travoprost one drop once daily in either the first or last 3 weeks of the study.
|
|---|---|---|
|
Intraocular Pressure
|
18.20 mm Hg
Standard Deviation 3.41
|
18.44 mm Hg
Standard Deviation 3.48
|
SECONDARY outcome
Timeframe: After 3 weeks of either the brand name or generic travoprostPopulation: There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms.
Patients will be asked about: 1. Difficulties related to administration of the drops 2. Compliance to the drops 3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash
Outcome measures
| Measure |
Brand Name Travoprost
n=70 Participants
Participants who received Brand Name Travoprost one drop once daily in either the first or last 3 weeks of the study.
|
Generic Travoprost
n=70 Participants
Participants who received Generic Travoprost one drop once daily in either the first or last 3 weeks of the study.
|
|---|---|---|
|
Comfort and Intolerance to the Drops Questionnaire
Did you have difficulties with the treatment? · Severe
|
0 Participants
|
6 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did you have difficulties with the treatment? · Mild
|
5 Participants
|
5 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did you have difficulties with the treatment? · Absent
|
65 Participants
|
59 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did you feel a burning sensation when administerin · Severe
|
4 Participants
|
3 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did you feel a burning sensation when administerin · Mild
|
13 Participants
|
16 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did you feel a burning sensation when administerin · Absent
|
53 Participants
|
51 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your vision get blurry when administering the · Severe
|
1 Participants
|
0 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your vision get blurry when administering the · Mild
|
13 Participants
|
12 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your vision get blurry when administering the · Absent
|
56 Participants
|
58 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your eyes get red when administering the drops · Severe
|
8 Participants
|
8 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your eyes get red when administering the drops · Mild
|
16 Participants
|
20 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Did your eyes get red when administering the drops · Absent
|
46 Participants
|
42 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Are your eyes dry? · Severe
|
4 Participants
|
3 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Are your eyes dry? · Mild
|
7 Participants
|
10 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Are your eyes dry? · Absent
|
59 Participants
|
57 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get tearing or secretions in your eyes? · Severe
|
1 Participants
|
2 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get tearing or secretions in your eyes? · Mild
|
10 Participants
|
10 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get tearing or secretions in your eyes? · Absent
|
59 Participants
|
58 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
When you feel pain in your eyes when administering · Severe
|
3 Participants
|
0 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
When you feel pain in your eyes when administering · Mild
|
4 Participants
|
7 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
When you feel pain in your eyes when administering · Absent
|
63 Participants
|
63 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do your eyes itch when administering the drops? · Severe
|
4 Participants
|
0 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do your eyes itch when administering the drops? · Mild
|
22 Participants
|
27 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do your eyes itch when administering the drops? · Absent
|
44 Participants
|
43 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get a rash on the skin around your eyes? · Severe
|
0 Participants
|
0 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get a rash on the skin around your eyes? · Mild
|
1 Participants
|
1 Participants
|
|
Comfort and Intolerance to the Drops Questionnaire
Do you get a rash on the skin around your eyes? · Absent
|
69 Participants
|
69 Participants
|
Adverse Events
Brand Name Travoprost
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Generic Travoprost
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brand Name Travoprost
n=76 participants at risk
Participants received Brand Name Travoprost one drop once daily for 3 weeks.
|
Generic Travoprost
n=76 participants at risk
Participants received Generic Travoprost one drop once daily for 3 weeks.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
1.3%
1/76 • Number of events 1 • Three weeks for each intervention.
Safety Population included all participants who received at least one dose of intervention.
|
0.00%
0/76 • Three weeks for each intervention.
Safety Population included all participants who received at least one dose of intervention.
|
|
Eye disorders
Transient blurry vision
|
1.3%
1/76 • Number of events 1 • Three weeks for each intervention.
Safety Population included all participants who received at least one dose of intervention.
|
0.00%
0/76 • Three weeks for each intervention.
Safety Population included all participants who received at least one dose of intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place