OTG Research & Consultancy
London, SW1E 6AU, United Kingdom
Completed
NCT Number: NCT01543061
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
OPTIVEtm Plus
Device1 drop in each eye four times a day for a period of 30 (± 3) days
No treatment
ProcedureOne month of contact lens wear with no eye drop use
Blink Contacts® Eye Drops
Device1 drop in each eye four times a day for a period of 30 (± 3) days
Other names: Blink Contacts®
Primary outcomes
-
Tear Break up Time
Time frame: 30 days
Secondary outcomes
-
Conjunctival staining measurement
Time frame: 30 days
-
Tear film evaporation rate
Time frame: 30 days
-
Ocular Surface Disease Index questionnaire
Time frame: 30 days
-
Comfort, vision and ocular symptoms questionnaire
Time frame: 30 days
-
Post wear contact lens deposition and lipid uptake assessment
Time frame: 30 days
Sponsors and collaborators
Lead sponsor
Optometric Technology Group Ltd
Other
Collaborators
- Allergan
Registry information
Official study title
Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Mar 2, 2012
- Registry last updated
- Sep 27, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.