A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.

Official Title
-----------------
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Device: BL-300-PFM04
* Device: OPTI-FREE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent Subjects must be habitual wearers of included contact lenses. Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month. Exclusion Criteria: • Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BL-300-PFM04<br> | Device: BL-300-PFM04<br>* Preservative Free Lubricating and Rewetting Drops for use during contact lens wear<br>|
| Active Comparator: Lubricating and rewetting drops<br> | Device: OPTI-FREE<br>* Replenish Rewetting Drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall comfort averaged over all follow-up visits | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits. | 1 month | 
| Dryness averaged over all follow-up visits | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits. | 1 month | 
| Proportion of eyes with slit lamp findings greater than grade 2 at any follow-up visit | At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present). | 1 month |