ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis (ZvL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01456780
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : June 19, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Meibomian Gland Dysfunction
Posterior Blepharitis
Interventions Drug: Loteprednol/tobramycin
Drug: Loteprednol
Drug: B+L Advanced Eye Relief Lubricant Drop
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description

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.

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

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.

Period Title: Overall Study
Started 20 20 20
Completed 17 17 20
Not Completed 3 3 0
Reason Not Completed
Lost to Follow-up             3             3             0
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops Total
Hide Arm/Group Description

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.

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

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 of all reporting groups
Overall Number of Baseline Participants 17 17 20 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 20 participants 54 participants
55  (13) 52  (12) 57  (12) 55  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 20 participants 54 participants
Female
8
  47.1%
9
  52.9%
15
  75.0%
32
  59.3%
Male
9
  52.9%
8
  47.1%
5
  25.0%
22
  40.7%
Ocular Surface Disease Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 17 participants 20 participants 54 participants
59.7  (18.0) 52.0  (22.6) 57.0  (21.3) 56.3  (20.6)
[1]
Measure Description: The Ocular Surface Disease Index score ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms
Symptom Assessment in Dry Eye (SANDE) Frequency Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 17 participants 20 participants 54 participants
77.8  (14.2) 60.9  (19.4) 68.1  (17.8) 68.9  (18.3)
[1]
Measure Description: 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.
Symptom Assessment in Dry Eye (SANDE) Severity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 17 participants 20 participants 54 participants
67.0  (19.8) 58.1  (19.6) 64.2  (19.5) 63.2  (19.6)
[1]
Measure Description: The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.
Corneal Fluorescein Staining (CFS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 17 participants 20 participants 54 participants
6.8  (2.6) 6.6  (2.5) 6.1  (2.0) 6.5  (2.3)
[1]
Measure Description: 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.
1.Primary Outcome
Title Ocular Surface Disease Index
Hide Description 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.
Time Frame Week 4 Time Point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description:

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.

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

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 Number of Participants Analyzed 17 17 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
56.6  (22.4) 46.4  (24.8) 48.4  (18.9)
2.Primary Outcome
Title Symptom Assessment iN Dry Eye (SANDE) Frequency Score
Hide Description Questionnaire 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.
Time Frame Week 4 Time Point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description:

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.

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

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 Number of Participants Analyzed 17 17 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
65.9  (28.9) 51.7  (23.3) 50.5  (24.3)
3.Primary Outcome
Title Symptom Assessment iN Dry Eye (SANDE) Severity Score
Hide Description Questionnaire 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.
Time Frame Week 4 Time Point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description:

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.

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

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 Number of Participants Analyzed 17 17 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.5  (25.8) 54.4  (20.2) 51.2  (22.0)
4.Primary Outcome
Title Corneal Fluorescein Staining Score
Hide Description Corneal 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.
Time Frame Week 4 Time Point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description:

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.

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

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 Number of Participants Analyzed 17 17 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (4.2) 5.0  (3.3) 4.8  (3.2)
Time Frame 4 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zylet Lotemax Bausch & Lomb Lubricant Drops
Hide Arm/Group Description

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.

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

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.

All-Cause Mortality
Zylet Lotemax Bausch & Lomb Lubricant Drops
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zylet Lotemax Bausch & Lomb Lubricant Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zylet Lotemax Bausch & Lomb Lubricant Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      1/20 (5.00%)      2/20 (10.00%)    
Eye disorders       
Eye Pain *  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Blurriness * 1  1/20 (5.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0
Excess Tearing * 2  1/20 (5.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Redness * 3  1/20 (5.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Headache * 4  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Shingles *  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Dryness * 5  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
1
Term from vocabulary, Blurriness
2
Term from vocabulary, Excess Tearing
3
Term from vocabulary, Redness
4
Term from vocabulary, Headache
5
Term from vocabulary, Dryness
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Reza Dana
Organization: Massachusetts Eye and Ear
Phone: 617-573-4431 ext 4431
Responsible Party: Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01456780     History of Changes
Other Study ID Numbers: 11-048H
First Submitted: August 2, 2011
First Posted: October 21, 2011
Results First Submitted: April 6, 2017
Results First Posted: June 19, 2017
Last Update Posted: August 1, 2017