Trial Outcomes & Findings for Tear Film Break-up Time After Instillation of Artificial Tears (NCT NCT00681265)
NCT ID: NCT00681265
Last Updated: 2012-10-26
Results Overview
State-of-the-art methodology to assess tear stability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
15 minutes after eye drop instillation
Results posted on
2012-10-26
Participant Flow
Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tear Film Break-up Time After Instillation of Artificial Tears
Baseline characteristics by cohort
| Measure |
Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop
n=16 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
44.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after eye drop instillationPopulation: Study N determined empirically by PI.
State-of-the-art methodology to assess tear stability.
Outcome measures
| Measure |
New Formulation of Glycerin 1% Eye Drop
n=16 Participants
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.
|
Propylene Glycol and PEG 400 Eye Drop
n=16 Participants
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.
|
|---|---|---|
|
Noninvasive Tear Film Break-up Time
|
14.67 seconds
Standard Deviation 27.21
|
7.4 seconds
Standard Deviation 30.30
|
SECONDARY outcome
Timeframe: 120 minutes after eye drops instillationPopulation: Study N determined empirically by PI.
Standard clinical assessment methodology for assessing tear stability.
Outcome measures
| Measure |
New Formulation of Glycerin 1% Eye Drop
n=16 Participants
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.
|
Propylene Glycol and PEG 400 Eye Drop
n=16 Participants
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.
|
|---|---|---|
|
Fluorescein Tear Film Break-up Time
|
11.13 seconds
Standard Deviation 12.08
|
6.21 seconds
Standard Deviation 4.86
|
Adverse Events
New Formulation of Glycerin 1% Eye Drop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propylene Glycol and PEG 400 Eye Drop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place