Trial Outcomes & Findings for The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction (NCT NCT01207752)
NCT ID: NCT01207752
Last Updated: 2025-04-01
Results Overview
time in seconds to observer a dark spot in the tear film
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Measured 2 hours after in-office administration of a single drop of test solution
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
Systane Balance
Artificial tear emulsion
Systane Balance: Artificial tear emulsion drop
|
Optive Lubricant Eye Drops
Artificial tear
Optive Lubricant Eye Drops: Artificial tear eye drop
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
Systane Balance
n=35 Participants
Artificial tear emulsion
Systane Balance: Artificial tear emulsion drop
|
Optive Lubricant Eye Drops
n=34 Participants
Artificial tear
Optive Lubricant Eye Drops: Artificial tear eye drop
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured 2 hours after in-office administration of a single drop of test solutiontime in seconds to observer a dark spot in the tear film
Outcome measures
| Measure |
Systane Balance
n=32 Participants
Artificial tear emulsion
Systane Balance: Artificial tear emulsion drop
|
Optive Lubricant Eye Drops
n=28 Participants
Artificial tear
Optive Lubricant Eye Drops: Artificial tear eye drop
|
|---|---|---|
|
Tear Film Breakup Time
|
4.65 seconds
Standard Deviation 1.73
|
4.42 seconds
Standard Deviation 1.14
|
Adverse Events
Systane Balance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optive Lubricant Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jerry Paugh, OD, PhD
Southern California College of Optometry at MBKU
Phone: 714-449-7487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER