Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
This study has been completed.
Sponsor:
Alcon Research
Collaborator:
Optometric Technology Group Ltd
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01368198
First received: May 6, 2011
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Other: Systane Balance Lubricating Eye Drops Other: OPTIVE™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Measurement of the tear film break-up time using DET sodium fluorescein strips. [ Time Frame: Enrollment Test visit 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. [ Time Frame: Enrollment Test visit 2 ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ocular Emulsion
An Ocular Emulsion
|
Other: Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
Other Names:
|
|
Active Comparator: OPTIVE™
An OPTIVE™
|
Other: OPTIVE™
One instillation of the eye drop in each eye
Other Name: Optive
|
Detailed Description:
The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- The subject must be 18 years of age or older;
- The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
- The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
- Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
- TFBUT measured with DET ≤ 5 seconds in at least one eye;
- Grade 1 for meibomian gland expression in both eyes;
- Evidence of missing meibomian glands in both eyes.
Exclusion Criteria:
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History or evidence of serious ocular trauma in either eye within the past six months.
- Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of any concomitant topical ocular medications during the study period.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
- Participation in an investigational drug or device study within 30 days of entering this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368198
Locations
| United States, Texas | |
| Contact Alcon Call Center for Trial Locations | |
| Fort Worth, Texas, United States, 76134 | |
| United Kingdom | |
| OTG Research & Consultancy | |
| London, England, United Kingdom, SW1E 6AU | |
Sponsors and Collaborators
Alcon Research
Optometric Technology Group Ltd
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01368198 History of Changes |
| Other Study ID Numbers: | ID11-10 |
| Study First Received: | May 6, 2011 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Alcon Research:
|
Ocular Emulsion OPTIVE™ Lubricant Tear Film Break Up Time |
Additional relevant MeSH terms:
|
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 16, 2013