An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01165164
First received: July 16, 2010
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Other: FID 115958D (lubricant eye drop) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Nighttime Use Assessment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]Nighttime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)
| Enrollment: | 89 |
| Study Start Date: | June 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FID 115958D
Lubricant eye drop
|
Other: FID 115958D (lubricant eye drop)
1 drop in each eye at bedtime
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented diagnosis of dry eye
- Current use of an eye ointment or tube gel
Exclusion Criteria:
- No nighttime contact lenses wear throughout the study period
- Must not have had punctal plugs inserted within 30 days preceding enrollment
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01165164 History of Changes |
| Other Study ID Numbers: | C-10-014 |
| Study First Received: | July 16, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Dry eye artificial tears |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013