Trial Outcomes & Findings for Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds (NCT NCT02164396)

Results Overview

LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 2-, 4-, 8- and 12-Week Follow-up

Results posted on

2018-06-19

Participant Flow

A total of 30 subjects were enrolled in this study. Of the enrolled subjects all 30 were dispensed study lenses and completed all study visits.

Participant milestones

Participant milestones
Measure	Spectacles Consists of subjects that were randomized to wear spectacles throughout the duration of the study.	Habitual Soft Contact Lens Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.	Senofilcon A or Narafilcon A Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spectacles n=10 Participants Consists of subjects that were randomized to wear spectacles throughout the duration of the study.	Habitual Soft Contact Lens n=10 Participants Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.	Senofilcon A or Narafilcon A n=10 Participants Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).	Total n=30 Participants Total of all reporting groups
Age, Continuous	35.40 years STANDARD_DEVIATION 10.013 • n=5 Participants	33.60 years STANDARD_DEVIATION 11.918 • n=7 Participants	29.0 years STANDARD_DEVIATION 9.821 • n=5 Participants	32.67 years STANDARD_DEVIATION 10.613 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized White	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Region of Enrollment Germany	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 2-, 4-, 8- and 12-Week Follow-up

Population: The analysis population consists of all subjects that completed the study without a major protocol deviation.

LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).

Outcome measures

Outcome measures
Measure	Spectacles n=20 observations Consists of subjects that were randomized to wear spectacles throughout the duration of the study.	Habitual Soft Contact Lens n=20 observations Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.	Senofilcon A or Narafilcon A n=20 observations Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
Lid-Parallel Conjunctival Folds (LIPCOF) Baseline	1.95 Score Standard Deviation 1.050	1.75 Score Standard Deviation 1.070	1.70 Score Standard Deviation 0.923
Lid-Parallel Conjunctival Folds (LIPCOF) 2-Week Follow-up	1.40 Score Standard Deviation 1.353	2.25 Score Standard Deviation 1.020	1.55 Score Standard Deviation 1.276
Lid-Parallel Conjunctival Folds (LIPCOF) 4-Week Follow-up	1.30 Score Standard Deviation 1.455	1.95 Score Standard Deviation 0.826	1.05 Score Standard Deviation 1.099
Lid-Parallel Conjunctival Folds (LIPCOF) 8-Week Follow-up	1.50 Score Standard Deviation 0.946	2.15 Score Standard Deviation 1.309	1.10 Score Standard Deviation 1.071
Lid-Parallel Conjunctival Folds (LIPCOF) 12- Week Follow-up	1.35 Score Standard Deviation 0.933	2.15 Score Standard Deviation 1.137	1.00 Score Standard Deviation 0.795

Adverse Events

Spectacles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Habitual Soft Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A or Narafilcon 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

Brian Pall, O.D., M.S.- Senior Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60