Acute Comfort of Lubricant Eye Drops FID 112903
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00673855
Collaborator
(none)
20
1
2
Study Details
Study Description
Brief Summary
To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lubricant Eye Drops FID 112903 Lubricant Eye Drops FID 112903 1 drop each eye one time |
Other: Lubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye 1 time
|
Active Comparator: Optive Lubricant Eye Drops Optive Lubricant Eye Drops 1 drop each eye 1 time |
Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops
|
Outcome Measures
Primary Outcome Measures
- Drop Comfort Upon Instillation [Three minutes]
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Documented diagnosis of dry eye
-
Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria:
- Age related
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mansfield | Mansfield | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00673855
Other Study ID Numbers:
- C-07-17
First Posted:
May 7, 2008
Last Update Posted:
Feb 2, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
Recruitment Details | 20 Dry Eye Subjects |
---|---|
Pre-assignment Detail | Randomized, double-masked, crossover |
Arm/Group Title | Lubricant Drops, Then Optive Drops | Optive Drops, Then Lubricant Drops |
---|---|---|
Arm/Group Description | Patients received lubricant Drops first, then received Optive Drops | Patients received Optive Drops first, then received Lubricant Drops |
Period Title: First Intervention | ||
STARTED | 10 | 10 |
COMPLETED | 10 | 10 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention | ||
STARTED | 10 | 10 |
COMPLETED | 10 | 10 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | |
Overall Participants | 20 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
18
90%
|
>=65 years |
2
10%
|
Sex: Female, Male (Count of Participants) | |
Female |
18
90%
|
Male |
2
10%
|
Outcome Measures
Title | Drop Comfort Upon Instillation |
---|---|
Description | Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable. |
Time Frame | Three minutes |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lubricant Eye Drops FID 112903 | Lubricant Eye Drops |
---|---|---|
Arm/Group Description | Lubricant Eye Drops FID 112903 | Lubricant Eye Drops |
Measure Participants | 20 | 20 |
Mean (Standard Deviation) [Units on a scale] |
1.1
(1.0)
|
1.4
(1.6)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Lubricant Eye Drops FID 112903 | Lubricant Eye Drops | ||
Arm/Group Description | Lubricant Eye Drops FID 112903 | Lubricant Eye Drops | ||
All Cause Mortality |
||||
Lubricant Eye Drops FID 112903 | Lubricant Eye Drops | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Lubricant Eye Drops FID 112903 | Lubricant Eye Drops | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Lubricant Eye Drops FID 112903 | Lubricant Eye Drops | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | 0/20 (0%) |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study.
Results Point of Contact
Name/Title | Alcon Clinical |
---|---|
Organization | Alcon Research, Ltd. |
Phone | 888.451.3937; 817.568.6725 |
medinfo@alconlabs.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00673855
Other Study ID Numbers:
- C-07-17
First Posted:
May 7, 2008
Last Update Posted:
Feb 2, 2012
Last Verified:
Jan 1, 2012