Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers
|ClinicalTrials.gov Identifier: NCT01339936|
Recruitment Status : Completed
First Posted : April 21, 2011
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||March 2011|
|Primary Completion Date :||August 2011|
|Study Completion Date :||May 2012|
Experimental: Investigational eye drop
Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80
1 drop in each eye three times a day for a period of 30 (± 4) days
- Tear Film Evaporation Rate [ Time Frame: after 30 days of eyedrop usage ]The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%.
- Tear Break Up Time [ Time Frame: after 30 days of eyedrop usage ]The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.
- Ocular Surface Disease Index Score [ Time Frame: after 30 days of eye drop usage ]
The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function.
The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339936
|OTG Research & Consultancy|
|London, England, United Kingdom, SW1E 6AU|