Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops (AKORN)
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|ClinicalTrials.gov Identifier: NCT02758327|
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Drug: TheraTears Lubricating Eye Drops||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: TheraTears Lubrication Drop
TheraTears Lubricating Eye Drops to be instilled 1 drop in both eyes 4 times per day over a period of 8 weeks.
Drug: TheraTears Lubricating Eye Drops
Sodium Carboxy-methylcellulose 0.25% eye Lubricant
Other Name: 87049747
- Change in Tear Osmolarity [ Time Frame: 8 weeks ]Osmolarity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in osmolarity over time.
- Change in Visual Acuity [ Time Frame: 8 weeks ]Visual acuity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in visual acuity over time.
- Change in Tear Film Breakup Time [ Time Frame: 8 Weeks ]After instillation of fluorescein, the investigator will ask the participant blink three times and keep their eyes open for as long as they can while the investigator records the time at which the dark spots on the tear film begin to appear.
- Change in Corneal Staining [ Time Frame: 8 weeks ]A fluorescein strip will be wetted with a few drops of saline, and applied to the inferior palpebral conjunctiva of both eyes. The eye will be illuminated by cobalt blue light, and viewed through a Wratten no. 12 barrier filter. Fluorescein staining will be assessed using the CCLRU8 scale (0 to 4).
- Change in Conjunctiva Staining [ Time Frame: 8 Weeks ]A lissamine green strip will be wetted and applied to the inferior palpebral conjunctiva of both eyes to assess conjunctival staining. Lissamine conjunctival staining will be assessed using the Oxford scale. If lissamine strip is not available, fluorescein maybe used instead to assess all conjunctival staining.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758327
|Study Director:||Diane Houtman, MD||Akorn Pharmaceuticals|