Dry Eye
Conditions
Keywords
rewetting, lubricating, eye drops
Brief summary
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
Interventions
DEVICEAMO Blink Contacts Lubricant Eye Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
DEVICELubricating and Rewetting Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * Use a lens care system on a regular basis. * Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day. * Willing to use drops 4 times per day.
Exclusion criteria
* Participating in a conflicting study. * An active ocular disease, any corneal infiltrative response, or are using any ocular medications. * Any scar or neovascularization within the central 4mm of the cornea. * Any grade 2 or greater finding during the slit lamp examination * Using any systemic or topical medications that will affect ocular physiology or lens performance. * Aphakic. * Amblyopic. * Allergic to any component in the study care products. * Have had any corneal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. | At 1 week follow up | Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities. |
Countries
United States
Participant flow
Recruitment details
There were 168 participants enrolled and 166 participants treated. The study was a cross-over study, so the 166 participants received both treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Overall The study was a cross-over study, so the 166 treated participants received both treatment groups. | 166 |
| Total | 166 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 166 | 0 / 166 |
| serious Total, serious adverse events | 0 / 166 | 0 / 166 |
Outcome results
Primary
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.
Time frame: At 1 week follow up
Population: There were 330 eyes evaluable for slit lamp findings in each group.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lubricating and Rewetting Drops | Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. | 1 eyes |
| AMO Blink Contacts Lubricant Eye Drops | Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. | 0 eyes |