Trial Outcomes & Findings for Direct Application of Systane Complete to Contact Lenses (NCT NCT03848221)

Results Overview

The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

73 participants

Primary outcome timeframe

2 Weeks

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Systane Complete Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Sensitive Eyes Rewetting Drops Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	No Treatment Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Overall Study STARTED	25	24	24
Overall Study COMPLETED	25	24	24
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Complete n=25 Participants Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Sensitive Eyes Rewetting Drops n=24 Participants Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	No Treatment n=24 Participants Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=73 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	73 Participants n=73 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=73 Participants
Sex: Female, Male Female	21 Participants n=25 Participants	19 Participants n=24 Participants	20 Participants n=24 Participants	60 Participants n=73 Participants
Sex: Female, Male Male	4 Participants n=25 Participants	5 Participants n=24 Participants	4 Participants n=24 Participants	13 Participants n=73 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	24 participants n=24 Participants	24 participants n=24 Participants	73 participants n=73 Participants

PRIMARY outcome

Timeframe: 2 Weeks

Population: Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.

The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Systane Complete n=25 Participants Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Sensitive Eyes Rewetting Drops n=24 Participants Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	No Treatment n=24 Participants Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks	0.44 Score on a Scale Standard Deviation 0.82	1.08 Score on a Scale Standard Deviation 1.32	0.83 Score on a Scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: 2 Weeks

Population: Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.

The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic.

Outcome measures

Outcome measures
Measure	Systane Complete n=25 Participants Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Sensitive Eyes Rewetting Drops n=24 Participants Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	No Treatment n=24 Participants Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.	-8.52 score on a scale Standard Deviation 2.97	-8.25 score on a scale Standard Deviation 2.42	-11.50 score on a scale Standard Deviation 3.08

Adverse Events

Systane Complete

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sensitive Eyes Rewetting Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

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

Dr. Andrew Pucker

The University of Alabama at Birmingham

Phone: 920-579-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place