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OpenTrials
Completed

NCT Number: NCT04175340

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

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.

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Key information

Conditions

Contact Lens Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch Site 108, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BL-300-PFM04

Device

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

OPTI-FREE

Device

Replenish Rewetting Drops

Primary outcomes

  1. Overall Comfort Averaged Over All Follow-up Visits

    Time frame: 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.

  2. Dryness Averaged Over All Follow-up Visits

    Time frame: 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.

  3. Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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