N/A
Completed N=369
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
Contact Lens Wear
Source: ClinicalTrials.gov NCT04175340 ↗
Enrolled (actual)
369
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Overall Comfort Averaged Over All Follow-up Visits — 91.72; 91.54 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort Averaged Over All Follow-up Visits |
91.72; 91.54 | — |
| PRIMARY Dryness Averaged Over All Follow-up Visits |
87.91; 87.01 | — |
| PRIMARY Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04175340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.