Trials Sponsors Conditions Drugs Pricing

Conditions

Contact Lens Wear

Outcome Measures

Primary Outcomes (3)

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.
1 month
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.
1 month
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).
1 month

Study Arms (2)

BL-300-PFM04

EXPERIMENTAL

Device: BL-300-PFM04

Lubricating and rewetting drops

ACTIVE COMPARATOR

Device: OPTI-FREE

Interventions

BL-300-PFM04Device

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

BL-300-PFM04

OPTI-FREEDevice

Replenish Rewetting Drops

Lubricating and rewetting drops

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (15)

Bausch Site 108

San Francisco, California, 94112, United States

Bausch Site 111

Torrance, California, 90503, United States

Bausch Site 106

Sarasota, Florida, 34237, United States

Bausch Site 104

Decatur, Georgia, 30035, United States

Bausch Site 110

Bloomington, Kansas, 61704, United States

Bausch Site 112

Leavenworth, Kansas, 66048, United States

Bausch Site 107

Portland, Maine, 04101, United States

Results Point of Contact

Title: Senior Manager, Clinical Trials
Organization: Bausch + Lomb Incorporated

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

369 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 25, 2019

Study Start

November 7, 2019

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

BL-300-PFM04

Lubricating and rewetting drops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

BL-300-PFM04

Lubricating and rewetting drops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations