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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339936
First Posted: April 21, 2011
Last Update Posted: November 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Optometric Technology Group Ltd
  Purpose
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 Intervention Phase
Dry Eye Syndrome Device: Carboxymethylcellulose sodium, glycerin and polysorbate 80 Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Optometric Technology Group Ltd:

Primary Outcome Measures:
  • 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:
  • 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.



Enrollment: 40
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United Kingdom
OTG Research & Consultancy
London, England, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Optometric Technology Group Ltd
Allergan
  More Information

Responsible Party: Optometric Technology Group Ltd
ClinicalTrials.gov Identifier: NCT01339936     History of Changes
Other Study ID Numbers: AG9965-005 ID 10-12
First Submitted: April 19, 2011
First Posted: April 21, 2011
Results First Submitted: January 30, 2013
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Glycerol
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cryoprotective Agents
Protective Agents
Laxatives
Gastrointestinal Agents