Tear Film Break-up Time After Instillation of Artificial Tears

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2008

Detailed 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.

Interventions

  • Drug: glycerin
    • Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
  • Drug: polyethylene glycol 400/propylene glycol
    • Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation

Arms, Groups and Cohorts

  • Experimental: glycerin
    • 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.
  • Active Comparator: polyethylene glycol 400/propylene glycol
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Noninvasive Tear Film Break-up Time
    • Time Frame: 15 minutes after eye drop instillation
    • State-of-the-art methodology to assess tear stability.

Secondary Measures

  • Fluorescein Tear Film Break-up Time
    • Time Frame: 120 minutes after eye drops instillation
    • Standard clinical assessment methodology for assessing tear stability.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Calm Water Therapeutics LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James V. Aquavella, MD, Principal Investigator, University of Rochester Eye Institute

References

Nichols JJ, Nichols KK, Puent B, Saracino M, Mitchell GL. Evaluation of tear film interference patterns and measures of tear break-up time. Optom Vis Sci. 2002 Jun;79(6):363-9. doi: 10.1097/00006324-200206000-00009.

Ousler GW, Michaelson C, Christensen MT. An evaluation of tear film breakup time extension and ocular protection index scores among three marketed lubricant eye drops. Cornea. 2007 Sep;26(8):949-52. doi: 10.1097/ICO.0b013e3180de1c38.

Cho P, Douthwaite W. The relation between invasive and noninvasive tear break-up time. Optom Vis Sci. 1995 Jan;72(1):17-22. doi: 10.1097/00006324-199501000-00004.

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