NCT00681265

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

2 months

First QC Date

May 19, 2008

Results QC Date

September 16, 2012

Last Update Submit

October 24, 2012

Conditions

Keratoconjunctivitis Sicca

Keywords

ocular lubricants

Outcome Measures

Primary Outcomes (1)

  • Noninvasive Tear Film Break-up Time

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

    15 minutes after eye drop instillation

Secondary Outcomes (1)

  • Fluorescein Tear Film Break-up Time

    120 minutes after eye drops instillation

Study Arms (2)

glycerin

EXPERIMENTAL

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.

Drug: glycerin

polyethylene glycol 400/propylene glycol

ACTIVE COMPARATOR

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.

Drug: polyethylene glycol 400/propylene glycol

Interventions

glycerinDRUG

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

Also known as: Eyeon Protect(TM)
glycerin
polyethylene glycol 400/propylene glycolDRUG

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

Also known as: Systane(R)
polyethylene glycol 400/propylene glycol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Eye Institute

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • 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.

    PMID: 12086302BACKGROUND

  • 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.

    PMID: 17721294BACKGROUND

  • 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.

    PMID: 7731650BACKGROUND

MeSH Terms

Conditions

Keratoconjunctivitis Sicca

Interventions

Glycerol

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
David M. Kleinman
Organization
Eyeon Therapeutics, Inc.
dave@eyeontherapeutics.com

Study Officials

  • James V. Aquavella, MD

    University of Rochester Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 26, 2012

Results First Posted

October 26, 2012

Record last verified: 2012-10

Locations

US(1)