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Completed

NCT Number: NCT00681265

Tear Film Break-up Time After Instillation of Artificial Tears

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.

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Eye Institute

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glycerin

Drug

Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.

Other names: Eyeon Protect(TM)

polyethylene glycol 400/propylene glycol

Drug

Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation

Other names: Systane(R)

Primary outcomes

  1. Noninvasive Tear Film Break-up Time

    Time frame: 15 minutes after eye drop instillation

    State-of-the-art methodology to assess tear stability.

Secondary outcomes

  1. Fluorescein Tear Film Break-up Time

    Time frame: 120 minutes after eye drops instillation

    Standard clinical assessment methodology for assessing tear stability.

Sponsors and collaborators

Lead sponsor

Calm Water Therapeutics LLC

Industry

Registry information

Official study title

A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 21, 2008
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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