Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02758327
Other study ID # ACH_PM_101_14
Secondary ID
Status Completed
Phase Phase 4
First received April 27, 2016
Last updated August 15, 2017
Start date October 2015
Est. completion date March 2016

Study information

Verified date August 2017
Source Koffler Vision Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Read more »

Study Design


Intervention

Drug:
TheraTears Lubricating Eye Drops
Sodium Carboxy-methylcellulose 0.25% eye Lubricant

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Koffler Vision Group Akorn, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT02597803 - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 Phase 2/Phase 3
Completed NCT02522312 - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients N/A
Completed NCT01863368 - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining N/A
Completed NCT01753752 - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation Phase 2
Completed NCT01753687 - Correlation of Different Signs for Assessment of Dry Eye Syndrome N/A
Completed NCT01198782 - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% Phase 4
Completed NCT01212471 - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease Phase 3
Completed NCT01162954 - Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers Phase 1
Completed NCT00544713 - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery N/A
Completed NCT00535054 - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms N/A
Completed NCT00344721 - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome N/A
Completed NCT03830359 - Efficacy, Safety of T2769 in Dry Eye Disease N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Completed NCT01970917 - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects Phase 4
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Completed NCT02092207 - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome Phase 2
Completed NCT01541891 - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome Phase 2
Completed NCT01252121 - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline N/A
Completed NCT00765804 - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye Phase 2
Completed NCT00514852 - Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye N/A