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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028754

Acronym

RLOTUS

Enrollment

180

Registered

2014-01-07

Start date

2011-07-31

Completion date

2013-05-31

Last updated

2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Cataract

Brief summary

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

Interventions

DRUGSodium Carboxymethylcellulose

Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.

DRUGLevofloxacin

Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.

DRUGPrednisolone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tear Break-Up Time (TBUT) in the Study Eye	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.

Secondary

Measure	Time frame	Description
Fluorescein Staining Score in the Study Eye	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	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.
Results of Schirmer I Test With Anesthetics in the Study Eye	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	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).
Subjective Symptom Total Score in the Study Eye	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).

Countries

China

Participant flow

Participants by arm

Arm	Count
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.	90
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.	90
Total	180

Baseline characteristics

Characteristic	Sodium Carboxymethylcellulose and Conventional Therapy	Conventional Therapy	Total
Age, Continuous	68.8 Years STANDARD_DEVIATION 7.1	69.0 Years STANDARD_DEVIATION 7.1	68.9 Years STANDARD_DEVIATION 7.1
Sex: Female, Male Female	54 Participants	59 Participants	113 Participants
Sex: Female, Male Male	36 Participants	31 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 86	0 / 85
serious Total, serious adverse events	0 / 86	0 / 85

Outcome results

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.

Time frame: Day 7