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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:
Collaborator:
Allergan
Information provided by (Responsible Party):
Optometric Technology Group Ltd
ClinicalTrials.gov Identifier:
NCT01339936
First received: April 19, 2011
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tear Break up Time [ Time Frame: after 30 days of eyedrop usage ] [ Designated as safety issue: No ]
  • Ocular Surface Disease Index score [ Time Frame: after 30 days of eye drop usage ] [ Designated as safety issue: No ]
  • Tear film lipid composition [ Time Frame: after 30 days of eyedrop usage ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339936

Locations
United Kingdom
OTG Research & Consultancy
London, England, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Optometric Technology Group Ltd
Allergan
  More Information

No publications provided

Responsible Party: Optometric Technology Group Ltd
ClinicalTrials.gov Identifier: NCT01339936     History of Changes
Other Study ID Numbers: AG9965-005 ID 10-12
Study First Received: April 19, 2011
Last Updated: July 12, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
 Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013