Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339936
• Other study ID #: AG9965-005 ID 10-12
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 19, 2011
• Last updated: September 26, 2013
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: Optometric Technology Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mild or greater dry eye symptoms.

• Evidence of evaporative dry eye

Exclusion Criteria:

• Known allergy or sensitivity to the study product(s) or its components

• Current contact lens wearer

• Systemic or ocular allergies

• Use of systemic medication which might have ocular side effects.

• Any ocular infection.

• Use of ocular medication.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Carboxymethylcellulose sodium, glycerin and polysorbate 80
1 drop in each eye three times a day for a period of 30 (± 4) days

Locations

Country	Name	City	State
United Kingdom	OTG Research & Consultancy	London	England

Sponsors (2)

Lead Sponsor	Collaborator
Optometric Technology Group Ltd	Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Film Evaporation Rate	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%.	after 30 days of eyedrop usage	No
Secondary	Tear Break Up Time	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.	after 30 days of eyedrop usage	No
Secondary	Ocular Surface Disease Index Score	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.	after 30 days of eye drop usage	No