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

Phase 4

Completed

• Conditions: Contact Lens Related Dry Eye Syndrome
• Interventions: Device: Blink Contacts® Eye Drops; Device: OPTIVEtm Plus; Procedure: No treatment

• Registration Number: NCT01543061
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-02
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BLINK Contacts Lubricating eye drop	Blink Contacts® Eye Drops	One month of contact lens wear with use of the Control study eye drops
New study eye drop	OPTIVEtm Plus	One month of contact lens wear with use of the Test study eye drops
No Eyedrop	No treatment	One month of contact lens wear with no eye drop use

Primary Outcome Measures

Name	Time	Method
Tear Break up Time	30 days

Secondary Outcome Measures

Name	Time	Method
Tear film evaporation rate	30 days
Comfort, vision and ocular symptoms questionnaire	30 days
Conjunctival staining measurement	30 days
Ocular Surface Disease Index questionnaire	30 days
Post wear contact lens deposition and lipid uptake assessment	30 days

Trial Locations

Locations (1)

OTG Research & Consultancy; 🇬🇧 London, United Kingdom