Tear Film Break-up Time After Instillation of Artificial Tears

Calm Water Therapeutics

Status: Completed

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: polyethylene glycol 400/propylene glycol; Drug: glycerin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681265

ET-001

Details and patient eligibility

About

This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Full description

Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years
• symptoms of dry eye
• no other history of ophthalmic problems

Exclusion criteria

• Use of any ocular lubricant or ointment in the past 36 hours
• use of contact lenses or excessive eye lid cosmetics on the study day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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16 participants in 2 patient groups

glycerin

Experimental group

Description:

One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.

Treatment:

Drug: glycerin

polyethylene glycol 400/propylene glycol

Active Comparator group

Description:

The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.

Treatment:

Drug: polyethylene glycol 400/propylene glycol