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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycerin | Drug | Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Tear Film Break-up Time | State-of-the-art methodology to assess tear stability. | 15 minutes after eye drop instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein Tear Film Break-up Time | Standard clinical assessment methodology for assessing tear stability. | 120 minutes after eye drops instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James V. Aquavella, MD | University of Rochester Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Eye Institute | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12086302 | Background | 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. | |
| 17721294 | Background | 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. |
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Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Noninvasive Tear Film Break-up Time | State-of-the-art methodology to assess tear stability. | Study N determined empirically by PI. | Posted | Mean | Standard Deviation | seconds | 15 minutes after eye drop instillation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Formulation of Glycerin 1% Eye Drop | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David M. Kleinman | Eyeon Therapeutics, Inc. | dave@eyeontherapeutics.com |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 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 |
|
|
| 7731650 | Background | 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Fluorescein Tear Film Break-up Time | Standard clinical assessment methodology for assessing tear stability. | Study N determined empirically by PI. | Posted | Mean | Standard Deviation | seconds | 120 minutes after eye drops instillation |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Propylene Glycol and PEG 400 Eye Drop | 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. | 0 | 16 | 0 | 16 |
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| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D002241 |
| Carbohydrates |