Trial Outcomes & Findings for Intraductal Meibomian Gland Probing Trial (NCT NCT02256969)
NCT ID: NCT02256969
Last Updated: 2017-06-19
Results Overview
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
4 week Time Point
Results posted on
2017-06-19
Participant Flow
Participant milestones
| Measure |
Meibomian Gland Probing Plus Lubricant
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Blephamide
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Meibomian Gland Probing Plus Lubricant
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Blephamide
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Overall Study
Screenfailed or withdrew
|
2
|
1
|
1
|
Baseline Characteristics
Intraductal Meibomian Gland Probing Trial
Baseline characteristics by cohort
| Measure |
Meibomian Gland Probing Plus Lubricant
n=13 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 Participants
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Blephamide
n=14 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 17.4 • n=206 Participants
|
61.1 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ocular Surface Disease Index (OSDI)
|
45.3 units on a scale
STANDARD_DEVIATION 23.8 • n=99 Participants
|
49.1 units on a scale
STANDARD_DEVIATION 27.1 • n=107 Participants
|
49.1 units on a scale
STANDARD_DEVIATION 19.9 • n=206 Participants
|
47.9 units on a scale
STANDARD_DEVIATION 23.3 • n=7 Participants
|
|
Symptom Assessment in Dry Eye (SANDE)
|
68.7 units on a scale
STANDARD_DEVIATION 15.4 • n=99 Participants
|
61.8 units on a scale
STANDARD_DEVIATION 22.5 • n=107 Participants
|
72.1 units on a scale
STANDARD_DEVIATION 14.1 • n=206 Participants
|
67.5 units on a scale
STANDARD_DEVIATION 17.8 • n=7 Participants
|
|
Corneal Fluorescein Staining (CFS)
|
1.9 units on a scale
STANDARD_DEVIATION 1.6 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 2.0 • n=107 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
|
Tear Film Break-Up Time (TBUT)
|
2.9 Seconds
STANDARD_DEVIATION 1.5 • n=99 Participants
|
3.0 Seconds
STANDARD_DEVIATION 1.5 • n=107 Participants
|
2.3 Seconds
STANDARD_DEVIATION 2.5 • n=206 Participants
|
3.0 Seconds
STANDARD_DEVIATION 1.9 • n=7 Participants
|
PRIMARY outcome
Timeframe: 4 week Time PointA 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Outcome measures
| Measure |
Meibomian Gland Probing Plus Blephamide
n=14 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Lubricant
n=13 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 Participants
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Ocular Surface Disease Index (OSDI)
|
37.3 units on a scale
Standard Deviation 21.0
|
38.7 units on a scale
Standard Deviation 20.3
|
36.9 units on a scale
Standard Deviation 28.2
|
PRIMARY outcome
Timeframe: 4 week Time PointA two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Outcome measures
| Measure |
Meibomian Gland Probing Plus Blephamide
n=14 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Lubricant
n=13 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 Participants
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE)
|
47.6 units on a scale
Standard Deviation 25.5
|
49.1 units on a scale
Standard Deviation 22.5
|
50.2 units on a scale
Standard Deviation 27.6
|
PRIMARY outcome
Timeframe: 4 week Time PointIs used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Outcome measures
| Measure |
Meibomian Gland Probing Plus Blephamide
n=14 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Lubricant
n=13 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 Participants
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Corneal Fluorescein Staining (CFS)
|
1.4 units on a scale
Standard Deviation 2.1
|
2.4 units on a scale
Standard Deviation 2.4
|
2.0 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 4 week Time PointTBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.
Outcome measures
| Measure |
Meibomian Gland Probing Plus Blephamide
n=14 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Lubricant
n=13 Participants
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 Participants
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Tear Break Up Time (TBUT)
|
3.2 Seconds
Standard Deviation 2.9
|
3.5 Seconds
Standard Deviation 2.4
|
4.2 Seconds
Standard Deviation 3.0
|
Adverse Events
Meibomian Gland Probing Plus Lubricant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Meibomian Gland Probing Plus Lubricant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Meibomian Gland Probing Plus Blephamide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Meibomian Gland Probing Plus Lubricant
n=13 participants at risk
Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Sham Meibomian Gland Probing Plus Lubricant
n=14 participants at risk
Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
|
Meibomian Gland Probing Plus Blephamide
n=14 participants at risk
Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
|
|---|---|---|---|
|
Eye disorders
Eye Pain
|
7.7%
1/13 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
14.3%
2/14 • 4 weeks
|
|
Eye disorders
Redness
|
0.00%
0/13 • 4 weeks
|
14.3%
2/14 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Eye disorders
Foreign Body Sensation
|
0.00%
0/13 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
Additional Information
Assistant Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary
Phone: 617-573-6060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place