A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: Lubricant Eye Drop; Other: Refresh Liquigel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294956

C-10-043

Details and patient eligibility

About

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of dry eye
• NaFl Corneal staining sum score ≥ 3 in either eye
• Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion criteria

• No contact lenses wear throughout the study period
• Must not have had punctal plugs inserted within 30 days preceding enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 2 patient groups

FID 115958D

Experimental group

Description:

Lubricant Eye Drop

Treatment:

Other: Lubricant Eye Drop

Refresh Liquigel

Active Comparator group

Description:

Lubricant Eye Drop

Treatment:

Other: Refresh Liquigel