Contact Lens Wear
Conditions
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.
Interventions
DEVICEBL-300-PFM04
Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
DEVICEOPTI-FREE
Replenish Rewetting Drops
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Averaged Over All Follow-up Visits | 1 month | 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 overall scheduled follow-up visits. |
| Dryness Averaged Over All Follow-up Visits | 1 month | 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. |
| Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit | 1 month | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BL-300-PFM04 BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear | 188 |
| Lubricating and Rewetting Drops OPTI-FREE: Replenish Rewetting Drops | 181 |
| Total | 369 |
Baseline characteristics
| Characteristic | Lubricating and Rewetting Drops | Total | BL-300-PFM04 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 181 Participants | 369 Participants | 188 Participants |
| Age, Continuous | 33.7 Years STANDARD_DEVIATION 8.57 | 34.6 Years STANDARD_DEVIATION 9.13 | 35.6 Years STANDARD_DEVIATION 9.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 27 Participants | 51 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 39 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 130 Participants | 274 Participants | 144 Participants |
| Region of Enrollment United States | 181 participants | 369 participants | 188 participants |
| Sex: Female, Male Female | 57 Participants | 117 Participants | 60 Participants |
| Sex: Female, Male Male | 124 Participants | 252 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 0 / 181 |
| other Total, other adverse events | 0 / 188 | 0 / 181 |
| serious Total, serious adverse events | 0 / 188 | 0 / 181 |
Outcome results
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BL-300-PFM04 | Dryness Averaged Over All Follow-up Visits | 87.91 units on a scale | Standard Deviation 13.332 |
| Lubricating and Rewetting Drops | Dryness Averaged Over All Follow-up Visits | 87.01 units on a scale | Standard Deviation 14.65 |
Primary
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 overall scheduled follow-up visits.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BL-300-PFM04 | Overall Comfort Averaged Over All Follow-up Visits | 91.72 units on a scale | Standard Deviation 9.988 |
| Lubricating and Rewetting Drops | Overall Comfort Averaged Over All Follow-up Visits | 91.54 units on a scale | Standard Deviation 10.68 |
Primary
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).
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BL-300-PFM04 | Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit | 0 Eyes |
| Lubricating and Rewetting Drops | Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit | 0 Eyes |