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

NCT01339936 | Completed Phase 2 Results

• 1 other identifier: AG9965-005 ID 10-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Tear Break Up Time

  after 30 days of eyedrop usage

• Ocular Surface Disease Index Score

  after 30 days of eye drop usage

Study Arms (1)

Investigational eye drop

EXPERIMENTAL

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

Interventions

Carboxymethylcellulose sodium, glycerin and polysorbate 80 DEVICE

1 drop in each eye three times a day for a period of 30 (± 4) days

Investigational eye drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild or greater dry eye symptoms.
• Evidence of evaporative dry eye

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optometric Technology Group Ltd: lead
• Allergan: collaborator

Study Sites (1)

OTG Research & Consultancy

London, England, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Michel Guillon
• Organization: Optometric Technology Group

mguillon@otg.co.uk

+44 2072224224

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 21, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: November 28, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

GB (1)