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Tear Film Break-up Time After Instillation of Artificial Tears

NCT ID: NCT00681265

Last Updated: 2012-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Keratoconjunctivitis Sicca

Keywords

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ocular lubricants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

glycerin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

polyethylene glycol 400/propylene glycol

Intervention Type DRUG

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

Interventions

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glycerin

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Eyeon Protect(TM) Systane(R)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Calm Water Therapeutics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James V. Aquavella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Eye Institute

Locations

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University of Rochester Eye Institute

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12086302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17721294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7731650 (View on PubMed)

Other Identifiers

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ET-001

Identifier Type: -

Identifier Source: org_study_id