Trial Outcomes & Findings for Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis (NCT NCT01456780)
NCT ID: NCT01456780
Last Updated: 2017-08-01
Results Overview
OSDI is 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
60 participants
Primary outcome timeframe
Week 4 Time Point
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
Zylet
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Zylet
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
0
|
Baseline Characteristics
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Baseline characteristics by cohort
| Measure |
Zylet
n=17 Participants
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=17 Participants
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 Participants
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 13 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12 • n=7 Participants
|
57 years
STANDARD_DEVIATION 12 • n=5 Participants
|
55 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ocular Surface Disease Index
|
59.7 units on a scale
STANDARD_DEVIATION 18.0 • n=5 Participants
|
52.0 units on a scale
STANDARD_DEVIATION 22.6 • n=7 Participants
|
57.0 units on a scale
STANDARD_DEVIATION 21.3 • n=5 Participants
|
56.3 units on a scale
STANDARD_DEVIATION 20.6 • n=4 Participants
|
|
Symptom Assessment in Dry Eye (SANDE) Frequency Score
|
77.8 units on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
|
60.9 units on a scale
STANDARD_DEVIATION 19.4 • n=7 Participants
|
68.1 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
68.9 units on a scale
STANDARD_DEVIATION 18.3 • n=4 Participants
|
|
Symptom Assessment in Dry Eye (SANDE) Severity Score
|
67.0 units on a scale
STANDARD_DEVIATION 19.8 • n=5 Participants
|
58.1 units on a scale
STANDARD_DEVIATION 19.6 • n=7 Participants
|
64.2 units on a scale
STANDARD_DEVIATION 19.5 • n=5 Participants
|
63.2 units on a scale
STANDARD_DEVIATION 19.6 • n=4 Participants
|
|
Corneal Fluorescein Staining (CFS)
|
6.8 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 2.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4 Time PointOSDI is 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.
Outcome measures
| Measure |
Zylet
n=17 Participants
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=17 Participants
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 Participants
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Ocular Surface Disease Index
|
56.6 units on a scale
Standard Deviation 22.4
|
46.4 units on a scale
Standard Deviation 24.8
|
48.4 units on a scale
Standard Deviation 18.9
|
PRIMARY outcome
Timeframe: Week 4 Time PointQuestionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.
Outcome measures
| Measure |
Zylet
n=17 Participants
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=17 Participants
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 Participants
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Symptom Assessment iN Dry Eye (SANDE) Frequency Score
|
65.9 units on a scale
Standard Deviation 28.9
|
51.7 units on a scale
Standard Deviation 23.3
|
50.5 units on a scale
Standard Deviation 24.3
|
PRIMARY outcome
Timeframe: Week 4 Time PointQuestionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.
Outcome measures
| Measure |
Zylet
n=17 Participants
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=17 Participants
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 Participants
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Symptom Assessment iN Dry Eye (SANDE) Severity Score
|
64.5 units on a scale
Standard Deviation 25.8
|
54.4 units on a scale
Standard Deviation 20.2
|
51.2 units on a scale
Standard Deviation 22.0
|
PRIMARY outcome
Timeframe: Week 4 Time PointCorneal Fluorescein Staining is 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 corneal epitheliopathy.
Outcome measures
| Measure |
Zylet
n=17 Participants
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=17 Participants
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 Participants
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Corneal Fluorescein Staining Score
|
6.3 units on a scale
Standard Deviation 4.2
|
5.0 units on a scale
Standard Deviation 3.3
|
4.8 units on a scale
Standard Deviation 3.2
|
Adverse Events
Zylet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lotemax
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bausch & Lomb Lubricant Drops
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zylet
n=20 participants at risk
Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
|
Lotemax
n=20 participants at risk
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling).
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
|
Bausch & Lomb Lubricant Drops
n=20 participants at risk
Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks.
|
|---|---|---|---|
|
Eye disorders
Eye Pain
|
5.0%
1/20 • Number of events 1 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
|
Eye disorders
Blurriness
|
5.0%
1/20 • Number of events 2 • 4 Weeks
|
5.0%
1/20 • Number of events 1 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
|
Eye disorders
Excess Tearing
|
5.0%
1/20 • Number of events 2 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
|
Eye disorders
Redness
|
5.0%
1/20 • Number of events 2 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
|
Eye disorders
Headache
|
0.00%
0/20 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
5.0%
1/20 • Number of events 1 • 4 Weeks
|
|
Eye disorders
Shingles
|
0.00%
0/20 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
5.0%
1/20 • Number of events 1 • 4 Weeks
|
|
Eye disorders
Dryness
|
0.00%
0/20 • 4 Weeks
|
5.0%
1/20 • Number of events 1 • 4 Weeks
|
0.00%
0/20 • 4 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place