Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

Official Title
-----------------
Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients

Conditions
-----------------
Conjunctival Staining

Intervention / Treatment
-----------------
* Device: Complete Easy Rub
* Device: ReNu MultiPlus
* Device: Clear Care
* Device: Contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successfully wearing hydrogel and/or silicone hydrogel contact lenses; Read, sign, and date informed consent/HIPAA document; Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles; Willing and able to discontinue contact lens wear when requested during the study; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Evidence or history of ocular disease or pathology; One functional eye or a monofit lens; Use of concomitant topical ocular prescription or over-the-counter ocular medications; History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReNu MultiPlus<br>ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. | Device: ReNu MultiPlus<br>* Commercially marketed contact lens solution for contact lens care<br>* Other names: ReNu MultiPlus®;Device: Contact lenses<br>* Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.<br>* Other names: ACUVUE® OASYS®;|
| Active Comparator: Complete Easy Rub<br>Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. | Device: Complete Easy Rub<br>* Commercially marketed contact lens solution for contact lens care<br>* Other names: Complete® Easy Rub®;Device: Contact lenses<br>* Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.<br>* Other names: ACUVUE® OASYS®;|
| Active Comparator: Clear Care<br>Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. | Device: Clear Care<br>* Commercially marketed contact lens solution for contact lens care<br>* Other names: Clear Care®;Device: Contact lenses<br>* Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.<br>* Other names: ACUVUE® OASYS®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Circumlimbal Conjunctival Staining Score | Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve. | Dispense (Day 0), 1 week | 
| Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter. | Dispense (Day 0), 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conjunctival Staining, lens parameters, lens fit