Back to resultsA Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms (RLOTUS)
Primary Purpose
Dry Eye Syndromes, Cataract
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sodium Carboxymethylcellulose
Levofloxacin
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of age-related cataract in the study eye
- Scheduled for cataract surgery and lens implant
Exclusion Criteria:
- Diagnosis of ocular surface disease or glaucoma
- Ocular surgery in the past 3 months
- Wearing a corneal contact lens in the study eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sodium Carboxymethylcellulose and Conventional Therapy
Conventional Therapy
Arm Description
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
Outcomes
Primary Outcome Measures
Tear Break-Up Time (TBUT) in the Study Eye
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Tear Break-Up Time (TBUT) in the Study Eye
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Secondary Outcome Measures
Fluorescein Staining Score in the Study Eye
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.
Lissamine Green Staining Score in the Study Eye
Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.
Results of Schirmer I Test With Anesthetics in the Study Eye
The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.
Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).
Subjective Symptom Total Score in the Study Eye
The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028754
Brief Title
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Acronym
RLOTUS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Carboxymethylcellulose and Conventional Therapy
Arm Type
Experimental
Arm Description
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
Intervention Type
Drug
Intervention Name(s)
Sodium Carboxymethylcellulose
Other Intervention Name(s)
Refresh Liquigel®
Intervention Description
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Cravit®
Intervention Description
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
PRED FORTE®
Intervention Description
Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.
Primary Outcome Measure Information:
Title
Tear Break-Up Time (TBUT) in the Study Eye
Description
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Time Frame
Day 7
Title
Tear Break-Up Time (TBUT) in the Study Eye
Description
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Fluorescein Staining Score in the Study Eye
Description
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.
Time Frame
Day 7, Day 30
Title
Lissamine Green Staining Score in the Study Eye
Description
Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.
Time Frame
Day 7, Day 30
Title
Results of Schirmer I Test With Anesthetics in the Study Eye
Description
The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.
Time Frame
Day 7, Day 30
Title
Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
Description
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).
Time Frame
Day 7, Day 30
Title
Subjective Symptom Total Score in the Study Eye
Description
The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).
Time Frame
Day 7, Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of age-related cataract in the study eye
Scheduled for cataract surgery and lens implant
Exclusion Criteria:
Diagnosis of ocular surface disease or glaucoma
Ocular surgery in the past 3 months
Wearing a corneal contact lens in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Hangzhou
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25880685
Citation
Yao K, Bao Y, Ye J, Lu Y, Bi H, Tang X, Zhao Y, Zhang J, Yang J. Efficacy of 1% carboxymethylcellulose sodium for treating dry eye after phacoemulsification: results from a multicenter, open-label, randomized, controlled study. BMC Ophthalmol. 2015 Mar 20;15:28. doi: 10.1186/s12886-015-0005-3.
Results Reference
derived
Learn more about this trial
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
We'll reach out to this number within 24 hrs