Keratoconjunctivitis Sicca
Conditions
Keywords
ocular lubricants
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.
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
DRUGglycerin
Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
DRUGpolyethylene glycol 400/propylene glycol
Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation
Sponsors
Calm Water Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive Tear Film Break-up Time | 15 minutes after eye drop instillation | State-of-the-art methodology to assess tear stability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Tear Film Break-up Time | 120 minutes after eye drops instillation | Standard clinical assessment methodology for assessing tear stability. |
Countries
United States
Participant flow
Recruitment details
Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age Continuous | 44.5 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Noninvasive Tear Film Break-up Time
State-of-the-art methodology to assess tear stability.
Time frame: 15 minutes after eye drop instillation
Population: Study N determined empirically by PI.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Formulation of Glycerin 1% Eye Drop | Noninvasive Tear Film Break-up Time | 14.67 seconds | Standard Deviation 27.21 |
| Propylene Glycol and PEG 400 Eye Drop | Noninvasive Tear Film Break-up Time | 7.4 seconds | Standard Deviation 30.3 |
Secondary
Fluorescein Tear Film Break-up Time
Standard clinical assessment methodology for assessing tear stability.
Time frame: 120 minutes after eye drops instillation
Population: Study N determined empirically by PI.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Formulation of Glycerin 1% Eye Drop | Fluorescein Tear Film Break-up Time | 11.13 seconds | Standard Deviation 12.08 |
| Propylene Glycol and PEG 400 Eye Drop | Fluorescein Tear Film Break-up Time | 6.21 seconds | Standard Deviation 4.86 |