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

Contact Lens Related Dry Eye Syndrome Clinical Trial

Official title:

Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543061
• Other study ID #: AG9965-006 ID 11-19
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2012
• Last updated: September 26, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Optometric Technology Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contact Lens Related Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• OPTIVEtm Plus
1 drop in each eye four times a day for a period of 30 (± 3) days

Procedure:
• No treatment
One month of contact lens wear with no eye drop use

Device:
• Blink Contacts® Eye Drops
1 drop in each eye four times a day for a period of 30 (± 3) days

Locations

Country	Name	City	State
United Kingdom	OTG Research & Consultancy	London

Sponsors (2)

Lead Sponsor	Collaborator
Optometric Technology Group Ltd	Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break up Time		30 days	No
Secondary	Conjunctival staining measurement		30 days	No
Secondary	Tear film evaporation rate		30 days	No
Secondary	Ocular Surface Disease Index questionnaire		30 days	No
Secondary	Comfort, vision and ocular symptoms questionnaire		30 days	No
Secondary	Post wear contact lens deposition and lipid uptake assessment		30 days	No