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

Not Applicable

Completed

• Conditions: Contact Lens Wear
• Interventions: Device: BL-300-PFM04; Device: OPTI-FREE

• Registration Number: NCT04175340
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-07
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Disposition First Submitted: 2021-02-12
• Status Verified: 2023-06
• Results First Submitted: 2023-08-31
• Results First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Results First Posted: 2024-07-10
• Disposition First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BL-300-PFM04	BL-300-PFM04	-
Lubricating and rewetting drops	OPTI-FREE	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (15)

Bausch Site 104; 🇺🇸 Decatur, Georgia, United States

Bausch Site 108; 🇺🇸 San Francisco, California, United States

Bausch Site 106; 🇺🇸 Sarasota, Florida, United States

Bausch Site 111; 🇺🇸 Torrance, California, United States

Bausch Site 109; 🇺🇸 Edina, Minnesota, United States

Bausch Site 102; 🇺🇸 Jamestown, New York, United States

Bausch Site 101; 🇺🇸 Miamisburg, Ohio, United States

Bausch Site 113; 🇺🇸 Vestal, New York, United States

Bausch Site 105; 🇺🇸 West Chester, Ohio, United States

Bausch Site 114; 🇺🇸 Grants Pass, Oregon, United States

Bausch Site 110; 🇺🇸 Bloomington, Kansas, United States

Bausch Site 112; 🇺🇸 Leavenworth, Kansas, United States

Bausch Site 115; 🇺🇸 Brentwood, Tennessee, United States

Bausch Site 103; 🇺🇸 Nashville, Tennessee, United States

Bausch Site 107; 🇺🇸 Portland, Maine, United States