Trial Outcomes & Findings for Central Corneal Swelling With Silicone Hydrogel Materials (NCT NCT02328937)

NCT ID: NCT02328937

Last Updated: 2018-06-19

Results Overview

Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 6-8 Hours Post lens insertion
• Results posted on: 2018-06-19

Participant Flow

A total of 41 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 38 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued while 36 completed all study visits.

Participant milestones

Measure	Etafilcon A/Lotrafilcon B/Comfilcon A Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.	Etafilcon A/Comfilcon A/Lotrafilcon B Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Lotrafilcon B/Etafilcon A/Comfilcon A Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.	Lotrafilcon B/Comfilcon A/Etafilcon A Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.	Comfilcon A/Etafilcon A/Lotrafilcon B Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Comfilcon A/Lotrafilcon B/Etafilcon A Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
Period 1 STARTED	7	6	7	6	6	6
Period 1 COMPLETED	7	6	7	5	6	6
Period 1 NOT COMPLETED	0	0	0	1	0	0
Period 2 STARTED	7	6	7	5	6	6
Period 2 COMPLETED	7	6	6	5	6	6
Period 2 NOT COMPLETED	0	0	1	0	0	0
Period 3 STARTED	7	6	6	5	6	6
Period 3 COMPLETED	7	6	6	5	6	6
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	Etafilcon A/Lotrafilcon B/Comfilcon A Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.	Etafilcon A/Comfilcon A/Lotrafilcon B Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Lotrafilcon B/Etafilcon A/Comfilcon A Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.	Lotrafilcon B/Comfilcon A/Etafilcon A Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.	Comfilcon A/Etafilcon A/Lotrafilcon B Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Comfilcon A/Lotrafilcon B/Etafilcon A Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
Period 1 Lost to Follow-up	0	0	0	1	0	0
Period 2 Adverse Event	0	0	1	0	0	0

Baseline Characteristics

Central Corneal Swelling With Silicone Hydrogel Materials

Baseline characteristics by cohort

Measure	Overall n=38 Participants All subjects that were dispensed at least one study lens.
Age, Continuous	32.9 years STANDARD_DEVIATION 8.71 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 participants n=5 Participants
Race/Ethnicity, Customized White	19 participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-8 Hours Post lens insertion

Population: All subjects that were dispensed at least one study lens throughout the duration of the study.

Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.

Outcome measures

Measure	Lotrafilcon B n=38 Participants Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.	Comfilcon A n=36 Participants Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.	Etafilcon A n=37 Participants Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
Central Corneal Swelling	542.4 um Standard Deviation 30.69	544.3 um Standard Deviation 28.30	542.2 um Standard Deviation 31.28

SECONDARY outcome

Timeframe: 6-8 hours post lens insertion

Population: All subjects that were dispensed at least one study lens throughout the duration of this study.

Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.

Outcome measures

Measure	Lotrafilcon B n=38 Participants Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.	Comfilcon A n=36 Participants Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.	Etafilcon A n=37 Participants Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
Limbal Redness	6.24 units on a scale Standard Deviation 1.177	6.14 units on a scale Standard Deviation 0.977	6.46 units on a scale Standard Deviation 1.233

Adverse Events

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A

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

Tawnya Wilson - PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision Care Inc.

Phone: +1 904 443-1834

Email: TWilson@ITS.JNJ.com

Results disclosure agreements

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

Restriction type: GT60