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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Zylet   Lotemax   Bausch & Lomb Lubricant Drops
STARTED   20   20   20 
COMPLETED   17   17   20 
NOT COMPLETED   3   3   0 
Lost to Follow-up                3                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Zylet   Lotemax   Bausch & Lomb Lubricant Drops   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   20   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (13)   52  (12)   57  (12)   55  (13) 
Sex: Female, Male 
[Units: Participants]
Count of 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 59.7  (18.0)   52.0  (22.6)   57.0  (21.3)   56.3  (20.6) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 77.8  (14.2)   60.9  (19.4)   68.1  (17.8)   68.9  (18.3) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 67.0  (19.8)   58.1  (19.6)   64.2  (19.5)   63.2  (19.6) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.8  (2.6)   6.6  (2.5)   6.1  (2.0)   6.5  (2.3) 
[1] 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

1.  Primary:   Ocular Surface Disease Index   [ Time Frame: Week 4 Time Point ]

2.  Primary:   Symptom Assessment iN Dry Eye (SANDE) Frequency Score   [ Time Frame: Week 4 Time Point ]

3.  Primary:   Symptom Assessment iN Dry Eye (SANDE) Severity Score   [ Time Frame: Week 4 Time Point ]

4.  Primary:   Corneal Fluorescein Staining Score   [ Time Frame: Week 4 Time Point ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Reza_Dana@meei.harvard.edu



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