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

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ClinicalTrials.gov Identifier: NCT01543061
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : September 27, 2013
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Optometric Technology Group Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Contact Lens Related Dry Eye Syndrome Device: OPTIVEtm Plus Procedure: No treatment Device: Blink Contacts® Eye Drops Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : February 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Tear Break up Time [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Conjunctival staining measurement [ Time Frame: 30 days ]
  2. Tear film evaporation rate [ Time Frame: 30 days ]
  3. Ocular Surface Disease Index questionnaire [ Time Frame: 30 days ]
  4. Comfort, vision and ocular symptoms questionnaire [ Time Frame: 30 days ]
  5. Post wear contact lens deposition and lipid uptake assessment [ Time Frame: 30 days ]


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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:

  • 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

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): 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

Responsible Party: Optometric Technology Group Ltd
ClinicalTrials.gov Identifier: NCT01543061     History of Changes
Other Study ID Numbers: AG9965-006 ID 11-19
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: September 27, 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
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents