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

NCT02028754 | Completed Phase 4 Results

• 1 other identifier: CN-CMC-1101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes; Cataract

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fluorescein Staining Score in the Study Eye

  Day 7, Day 30

• Lissamine Green Staining Score in the Study Eye

  Day 7, Day 30

• Results of Schirmer I Test With Anesthetics in the Study Eye

  Day 7, Day 30

• Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye

  Day 7, Day 30

• Subjective Symptom Total Score in the Study Eye

  Day 7, Day 30

Study Arms (2)

Sodium Carboxymethylcellulose and Conventional Therapy

EXPERIMENTAL

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; Drug: Levofloxacin; Drug: Prednisolone

Conventional Therapy

ACTIVE COMPARATOR

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; Drug: Prednisolone

Interventions

Sodium Carboxymethylcellulose DRUG

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

Also known as: Refresh Liquigel®

Sodium Carboxymethylcellulose and Conventional Therapy

Levofloxacin DRUG

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

Also known as: Cravit®

Conventional Therapy; Sodium Carboxymethylcellulose and Conventional Therapy

Prednisolone DRUG

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.

Also known as: PRED FORTE®

Conventional Therapy; Sodium Carboxymethylcellulose and Conventional Therapy

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of age-related cataract in the study eye
• Scheduled for cataract surgery and lens implant

You may not qualify if:

• Diagnosis of ocular surface disease or glaucoma
• Ocular surgery in the past 3 months
• Wearing a corneal contact lens in the study eye

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Hangzhou, China

Location

Related Publications (1)

• Yao K, Bao Y, Ye J, Lu Y, Bi H, Tang X, Zhao Y, Zhang J, Yang J. Efficacy of 1% carboxymethylcellulose sodium for treating dry eye after phacoemulsification: results from a multicenter, open-label, randomized, controlled study. BMC Ophthalmol. 2015 Mar 20;15:28. doi: 10.1186/s12886-015-0005-3.

  PMID: 25880685 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Interventions

Carboxymethylcellulose Sodium; Levofloxacin; Prednisolone; prednisolone acetate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03

Locations

CN (1)