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

Cataract Clinical Trial

— RLOTUS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028754
• Other study ID #: CN-CMC-1101
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2014
• Last updated: March 19, 2014
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Sodium Carboxymethylcellulose
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.
• Levofloxacin
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
• Prednisolone
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No