Contact Lens Related Dry Eye Syndrome
Conditions
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.
Interventions
DEVICEOPTIVEtm Plus
1 drop in each eye four times a day for a period of 30 (± 3) days
PROCEDURENo treatment
One month of contact lens wear with no eye drop use
DEVICEBlink Contacts® Eye Drops
1 drop in each eye four times a day for a period of 30 (± 3) days
Sponsors
Allergan
Optometric Technology Group Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Break up Time | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Post wear contact lens deposition and lipid uptake assessment | 30 days |
| Conjunctival staining measurement | 30 days |
| Tear film evaporation rate | 30 days |
| Ocular Surface Disease Index questionnaire | 30 days |
| Comfort, vision and ocular symptoms questionnaire | 30 days |
Countries
United Kingdom
Outcome results
None listed