Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops (AKORN)

Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating

The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: TheraTears Lubricating Eye Drops

Detailed Description

Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity than observed in normal subjects, this is thought to relate to the inherent tear film instability of dry eye disease. Lubricating eye drops are frequently prescribed to relieve the symptoms of dry eye.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is at least 21 years of age and has full legal capacity to volunteer;
2. Has read and signed the information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
5. Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point difference between the two eyes.

Exclusion Criteria:

1. Has taken part in another research study within the last 30 days;
2. Planned contact lens wear during the course of the study;
3. Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
4. Any subject that violates the washout period by using eye drops during the 72hrs washout period;
5. Has any known ocular disease* including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
6. Restasis use can be included if they have been on it for at least 3 months and are stable.Used Restasis (or similar topical medication) within the last 6 months;
7. Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
9. Use of systemic anti-histamines, as long as they have been on them continuously for at least 1 month. Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
10. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

11. Has undergone ocular surgery(LASIK, Cataract, etc)within the last year;

    • For purposes of this study, ocular conditions that are typically associated with dry eye status, such as meibomian gland dysfunction, mild (i.e. not considered clinically relevant) blepharitis, corneal and conjunctival staining are not considered an exclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 87049747

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tear Osmolarity	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Acuity	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.	8 weeks
Change in Tear Film Breakup Time	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.	8 Weeks
Change in Corneal Staining	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).	8 weeks
Change in Conjunctiva Staining	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.	8 Weeks

Collaborators and Investigators

• Sponsor: Koffler Vision Group
• Collaborators: Akorn, Inc.
• Investigators: Study Director: Diane Houtman, MD, Akorn Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ocular Surface Disease; Tear Osmolarity; Keratitis Sicca; TheraTears
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Gastrointestinal Agents; Pharmaceutical Solutions; Laxatives; Ophthalmic Solutions; Lubricant Eye Drops; Carboxymethylcellulose Sodium
• Other Study ID Numbers: ACH_PM_101_14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided