A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms

Study Overview
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Brief Summary
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This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.

Conditions
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Dry Eye Syndromes, Cataract

Intervention / Treatment
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* Drug: Sodium Carboxymethylcellulose
* Drug: Levofloxacin
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Carboxymethylcellulose and Conventional Therapy<br>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. | Drug: Sodium Carboxymethylcellulose<br>* Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.<br>* Other names: Refresh Liquigel®;Drug: Levofloxacin<br>* Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.<br>* Other names: Cravit®;Drug: Prednisolone<br>* 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.<br>* Other names: PRED FORTE®;|
| Active Comparator: Conventional Therapy<br>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. | Drug: Levofloxacin<br>* Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.<br>* Other names: Cravit®;Drug: Prednisolone<br>* 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.<br>* Other names: PRED FORTE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7 | 
| 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7, Day 30 | 
| 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. | Day 7, Day 30 | 
| 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. | Day 7, Day 30 | 
| 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). | Day 7, Day 30 | 
| 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). | Day 7, Day 30 |