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

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ClinicalTrials.gov Identifier: NCT01339936
Recruitment Status : Completed
First Posted : April 21, 2011
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Optometric Technology Group Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : March 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339936


Locations
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United Kingdom
OTG Research & Consultancy
London, England, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Optometric Technology Group Ltd
Allergan
More Information
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Responsible Party: Optometric Technology Group Ltd
ClinicalTrials.gov Identifier: NCT01339936    
Other Study ID Numbers: AG9965-005 ID 10-12
First Posted: April 21, 2011    Key Record Dates
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
 Corneal Diseases
Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs