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

NCT ID: NCT02028754

Last Updated: 2014-04-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye Syndromes Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sodium Carboxymethylcellulose

Intervention Type DRUG

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

Levofloxacin

Intervention Type DRUG

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

Prednisolone

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Levofloxacin

Intervention Type DRUG

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

Prednisolone

Intervention Type 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.

Interventions

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Sodium Carboxymethylcellulose

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

Intervention Type DRUG

Levofloxacin

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Refresh Liquigel® Cravit® PRED FORTE®

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Hangzhou, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 25880685 (View on PubMed)

Other Identifiers

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CN-CMC-1101

Identifier Type: -

Identifier Source: org_study_id

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