Tear Film Break-up Time After Instillation of Artificial Tears

• Sponsor: Eyeon Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00681265
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: glycerin; Drug: polyethylene glycol 400/propylene glycol	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: glycerin; 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)
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.	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; Other Names: Systane(R)

Outcome Measures

Primary Outcome Measures

1. Noninvasive Tear Film Break-up Time [15 minutes after eye drop instillation]

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

Secondary Outcome Measures

1. Fluorescein Tear Film Break-up Time [120 minutes after eye drops instillation]

   Standard clinical assessment methodology for assessing tear stability.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Eye Institute	Rochester	New York	United States	14642

Sponsors and Collaborators

• Eyeon Therapeutics, Inc.

Investigators

• Principal Investigator: James V. Aquavella, MD, University of Rochester Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Eyeon Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT00681265
• Other Study ID Numbers: ET-001
• First Posted: May 21, 2008
• Last Update Posted: Oct 26, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Eyeon Therapeutics, Inc.: ocular lubricants
• Additional relevant MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Glycerol

Study Results

Participant Flow

Recruitment Details	Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.

Arm/Group Title	Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop
Arm/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. 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.
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop
Arm/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. 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.
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	10 62.5%
Male	6 37.5%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study N determined empirically by PI.

Arm/Group Title	New Formulation of Glycerin 1% Eye Drop	Propylene Glycol and PEG 400 Eye Drop
Arm/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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [seconds]	14.67 (27.21)	7.4 (30.30)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study N determined empirically by PI.

Arm/Group Title	New Formulation of Glycerin 1% Eye Drop	Propylene Glycol and PEG 400 Eye Drop
Arm/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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [seconds]	11.13 (12.08)	6.21 (4.86)

Adverse Events

Arm/Group Title	New Formulation of Glycerin 1% Eye Drop		Propylene Glycol and PEG 400 Eye Drop
Arm/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.		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.
All Cause Mortality
	New Formulation of Glycerin 1% Eye Drop		Propylene Glycol and PEG 400 Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	New Formulation of Glycerin 1% Eye Drop		Propylene Glycol and PEG 400 Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	New Formulation of Glycerin 1% Eye Drop		Propylene Glycol and PEG 400 Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.