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

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

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:
  • Refresh Liquigel®
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other Names:
  • Cravit®
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:
  • PRED FORTE®
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:
  • Cravit®
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:
  • PRED FORTE®

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

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.

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