Trial Outcomes & Findings for Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction (NCT NCT00755183)
NCT ID: NCT00755183
Last Updated: 2020-10-22
Results Overview
The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
168 days
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Testosterone Ophthalmic Solution
testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Vehicle
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Testosterone Ophthalmic Solution
testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Vehicle
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Administrative
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
Testosterone Ophthalmic Solution
n=30 Participants
testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Vehicle
n=30 Participants
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Continuous
|
69.57 years
STANDARD_DEVIATION 6.730 • n=99 Participants
|
68.10 years
STANDARD_DEVIATION 6.764 • n=107 Participants
|
68.83 years
STANDARD_DEVIATION 6.730 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 168 daysThe average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.
Outcome measures
| Measure |
Testosterone Ophthalmic Solution
n=18 Participants
testosterone ophthalmic solution 0.03%
testosterone ophthalmic solution: testosterone ophthalmic solution for 128 days
|
Vehicle
n=17 Participants
vehicle of testosterone ophthalmic solution
vehicle of testosterone ophthalmic solution: vehicle of testosterone ophthalmic solution for 128 days
|
|---|---|---|
|
Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
|
0.80 units on a scale
Standard Deviation 0.50
|
0.96 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: 168 daysOcular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)
Outcome measures
| Measure |
Testosterone Ophthalmic Solution
n=18 Participants
testosterone ophthalmic solution 0.03%
testosterone ophthalmic solution: testosterone ophthalmic solution for 128 days
|
Vehicle
n=17 Participants
vehicle of testosterone ophthalmic solution
vehicle of testosterone ophthalmic solution: vehicle of testosterone ophthalmic solution for 128 days
|
|---|---|---|
|
Ocular Discomfort Score at Visit 4
|
1.70 score on a scale
Standard Deviation 0.6
|
1.33 score on a scale
Standard Deviation 0.6
|
Adverse Events
Testosterone Ophthalmic Solution
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Ophthalmic Solution
n=30 participants at risk
testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Vehicle
n=30 participants at risk
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
|
|---|---|---|
|
Nervous system disorders
Essential tremor
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
0.00%
0/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
0.00%
0/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
0.00%
0/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
Other adverse events
| Measure |
Testosterone Ophthalmic Solution
n=30 participants at risk
testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days.
|
Vehicle
n=30 participants at risk
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
6.7%
2/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
3.3%
1/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
10.0%
3/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
|
Infections and infestations
Rhinitis
|
6.7%
2/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
3.3%
1/30 • Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
|
Additional Information
Dr. Mark Abelson
Andover Eye
Phone: 9784750705
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place