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Trial Outcomes & Findings for A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop (NCT NCT04175340)

NCT ID: NCT04175340

Last Updated: 2024-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

369 participants

Primary outcome timeframe

1 month

Results posted on

2024-07-10

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure
BL-300-PFM04
BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Lubricating and Rewetting Drops
OPTI-FREE: Replenish Rewetting Drops
Overall Study
STARTED
188 376
181 362
Overall Study
COMPLETED
188 376
181 362
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BL-300-PFM04
n=188 Participants
BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Lubricating and Rewetting Drops
n=181 Participants
OPTI-FREE: Replenish Rewetting Drops
Total
n=369 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
188 Participants
n=5 Participants
181 Participants
n=7 Participants
369 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
35.6 Years
STANDARD_DEVIATION 9.56 • n=5 Participants
33.7 Years
STANDARD_DEVIATION 8.57 • n=7 Participants
34.6 Years
STANDARD_DEVIATION 9.13 • n=5 Participants
Sex: Female, Male
Female
60 Participants
n=5 Participants
57 Participants
n=7 Participants
117 Participants
n=5 Participants
Sex: Female, Male
Male
128 Participants
n=5 Participants
124 Participants
n=7 Participants
252 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
24 Participants
n=5 Participants
27 Participants
n=7 Participants
51 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=5 Participants
21 Participants
n=7 Participants
39 Participants
n=5 Participants
Race (NIH/OMB)
White
144 Participants
n=5 Participants
130 Participants
n=7 Participants
274 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
188 participants
n=5 Participants
181 participants
n=7 Participants
369 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
BL-300-PFM04
n=368 Eyes
BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Lubricating and Rewetting Drops
n=354 Eyes
OPTI-FREE: Replenish Rewetting Drops
Overall Comfort Averaged Over All Follow-up Visits
91.72 units on a scale
Standard Deviation 9.988
91.54 units on a scale
Standard Deviation 10.680

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
BL-300-PFM04
n=368 Eyes
BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Lubricating and Rewetting Drops
n=354 Eyes
OPTI-FREE: Replenish Rewetting Drops
Dryness Averaged Over All Follow-up Visits
87.91 units on a scale
Standard Deviation 13.332
87.01 units on a scale
Standard Deviation 14.650

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
BL-300-PFM04
n=374 Eyes
BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Lubricating and Rewetting Drops
n=360 Eyes
OPTI-FREE: Replenish Rewetting Drops
Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit
0 Eyes
0 Eyes

Adverse Events

BL-300-PFM04

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lubricating and Rewetting Drops

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Manager, Clinical Trials

Bausch + Lomb Incorporated

Phone: (585) 623-9588

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place