- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02028754
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms (RLOTUS)
March 19, 2014 updated by: Allergan
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hangzhou, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium Carboxymethylcellulose and Conventional Therapy
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.
|
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.
Other Names:
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other Names:
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.
Other Names:
|
Active Comparator: Conventional Therapy
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.
|
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tear Break-Up Time (TBUT) in the Study Eye
Time Frame: Day 7
|
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.
|
Day 7
|
Tear Break-Up Time (TBUT) in the Study Eye
Time Frame: Day 30
|
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.
|
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluorescein Staining Score in the Study Eye
Time Frame: Day 7, Day 30
|
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.
|
Day 7, Day 30
|
Lissamine Green Staining Score in the Study Eye
Time Frame: Day 7, Day 30
|
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.
|
Day 7, Day 30
|
Results of Schirmer I Test With Anesthetics in the Study Eye
Time Frame: Day 7, Day 30
|
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.
|
Day 7, Day 30
|
Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
Time Frame: Day 7, Day 30
|
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).
|
Day 7, Day 30
|
Subjective Symptom Total Score in the Study Eye
Time Frame: Day 7, Day 30
|
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).
|
Day 7, Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 6, 2014
First Submitted That Met QC Criteria
January 6, 2014
First Posted (Estimate)
January 7, 2014
Study Record Updates
Last Update Posted (Estimate)
April 23, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lens Diseases
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Cataract
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Laxatives
- Anti-Infective Agents, Urinary
- Renal Agents
- Prednisolone
- Prednisolone acetate
- Levofloxacin
- Ofloxacin
- Carboxymethylcellulose Sodium
Other Study ID Numbers
- CN-CMC-1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cataract
-
Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
-
Johannes Kepler University of LinzCompletedCataract Complicated | Cataract Complications OperationsAustria
-
Gemini Eye ClinicRecruitingBilateral Cataract | Unilateral CataractCzechia
-
Universitaire Ziekenhuizen KU LeuvenLaboratoires TheaRecruiting
-
Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
-
Yonsei UniversityCompletedCataract PatientsKorea, Republic of
-
Johannes Kepler University of LinzRecruitingAphakia | Secondary Cataract Surgery | Complicated Cataract SurgeryAustria
-
Advanced Center for Eyecare GlobalNot yet recruiting
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingCataract ExtractionChina
Clinical Trials on Sodium Carboxymethylcellulose
-
AllerganCompletedDry Eye SyndromesCanada, Australia
-
AllerganCompletedBilateral LASIK SurgeryAustralia, Canada
-
AllerganCompletedDry Eye SyndromesUnited States, Australia
-
AllerganCompletedContact Lens LubricationUnited States
-
Medline IndustriesCompletedVenous Leg UlcerUnited States
-
AllerganCompleted
-
Milton S. Hershey Medical CenterWithdrawn
-
University College DublinRecruitingHypoglycemia in Newborn InfantsCzechia, Ireland
-
Chulalongkorn UniversityCompleted
-
Massachusetts General HospitalGelesis, Inc.CompletedConstipation | Irritable Bowel Syndrome With Constipation | Chronic Idiopathic ConstipationUnited States