Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Optometric Technology Group Ltd
ClinicalTrials.gov Identifier:
NCT01543061
First received: February 22, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.


Condition Intervention Phase
Contact Lens Related Dry Eye Syndrome
Device: OPTIVEtm Plus
Procedure: No treatment
Device: Blink Contacts® Eye Drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

Resource links provided by NLM:


Further study details as provided by Optometric Technology Group Ltd:

Primary Outcome Measures:
  • Tear Break up Time [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conjunctival staining measurement [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Tear film evaporation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ocular Surface Disease Index questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Comfort, vision and ocular symptoms questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Post wear contact lens deposition and lipid uptake assessment [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: New study eye drop
One month of contact lens wear with use of the Test study eye drops
Device: OPTIVEtm Plus
1 drop in each eye four times a day for a period of 30 (± 3) days
Placebo Comparator: No Eyedrop
One month of contact lens wear with no eye drop use
Procedure: No treatment
One month of contact lens wear with no eye drop use
Active Comparator: BLINK Contacts Lubricating eye drop
One month of contact lens wear with use of the Control study eye drops
Device: Blink Contacts® Eye Drops
1 drop in each eye four times a day for a period of 30 (± 3) days
Other Name: Blink Contacts®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Current silicone hydrogel contact lens wearer
  • Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria:

  • Known allergy or sensitivity to the study product(s) or its components
  • Systemic or ocular allergies
  • Use of systemic medication which might have ocular side effects.
  • Any ocular infection.
  • Use of ocular medication.
  • Significant ocular tissue anomaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543061

Locations
United Kingdom
OTG Research & Consultancy
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Optometric Technology Group Ltd
Allergan
Investigators
Principal Investigator: Michel Guillon, PhD Optometric Technology Group Ltd
  More Information

No publications provided

Responsible Party: Optometric Technology Group Ltd
ClinicalTrials.gov Identifier: NCT01543061     History of Changes
Other Study ID Numbers: AG9965-006 ID 11-19
Study First Received: February 22, 2012
Last Updated: September 26, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 18, 2014