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

Allergan

Status and phase: Completed; Phase 4

Conditions: Cataract; Dry Eye Syndromes

Treatments: Drug: Prednisolone; Drug: Levofloxacin; Drug: Sodium Carboxymethylcellulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028754

CN-CMC-1101

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Sodium Carboxymethylcellulose and Conventional Therapy

Experimental group

Description:

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.

Treatment:

Drug: Sodium Carboxymethylcellulose

Drug: Levofloxacin

Drug: Prednisolone

Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Levofloxacin

Drug: Prednisolone