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

NCT02758327 | Completed Phase 4 DMC

• 1 other identifier: ACH_PM_101_14
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye Syndrome

Keywords

Tear Osmolarity; Keratitis Sicca; Ocular Surface Disease; TheraTears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Visual Acuity

  8 weeks

• Change in Tear Film Breakup Time

  8 Weeks

• Change in Corneal Staining

  8 weeks

• Change in Conjunctiva Staining

  8 Weeks

Study Arms (1)

TheraTears Lubrication Drop

EXPERIMENTAL

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

Interventions

TheraTears Lubricating Eye Drops DRUG

Sodium Carboxy-methylcellulose 0.25% eye Lubricant

Also known as: 87049747

TheraTears Lubrication Drop

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 21 years of age and has full legal capacity to volunteer;
• Has read and signed the information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• 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;
• 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.

You may not qualify if:

• Has taken part in another research study within the last 30 days;
• Planned contact lens wear during the course of the study;
• Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
• Any subject that violates the washout period by using eye drops during the 72hrs washout period;
• Has any known ocular disease\* including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
• 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;
• 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;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
• 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;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Has undergone ocular surgery(LASIK, Cataract, etc)within the last year;

Sponsors & Collaborators

• Koffler Vision Group: lead
• Akorn, Inc.: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes; Keratitis sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Diane Houtman, MD

  Akorn Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08