Hangzhou, China
NCT Number: NCT02028754
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.
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Notify MeKey information
Age range
60 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sodium Carboxymethylcellulose
DrugSodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.
Other names: Refresh Liquigel®
Levofloxacin
DrugLevofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other names: Cravit®
Prednisolone
DrugPrednisolone 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: PRED FORTE®
Primary outcomes
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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.
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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.
Secondary outcomes
-
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.
-
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.
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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.
-
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).
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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).
Sponsors and collaborators
Lead sponsor
Allergan
Industry
Registry information
Acronym: RLOTUS
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jan 7, 2014
- Registry last updated
- Apr 23, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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