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Trial record 1 of 1 for:    NCT02028754
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A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms (RLOTUS)

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ClinicalTrials.gov Identifier: NCT02028754
Recruitment Status : Completed
First Posted : January 7, 2014
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Cataract Drug: Sodium Carboxymethylcellulose Drug: Levofloxacin Drug: Prednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


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

Drug: Levofloxacin
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other Name: Cravit®

Drug: 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.
Other Name: 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.
Drug: Levofloxacin
Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
Other Name: Cravit®

Drug: 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.
Other Name: PRED FORTE®




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028754


Locations
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China
Hangzhou, China
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02028754     History of Changes
Other Study ID Numbers: CN-CMC-1101
First Posted: January 7, 2014    Key Record Dates
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Cataract
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Lens Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Levofloxacin
Ofloxacin
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Carboxymethylcellulose Sodium
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents