Lid-Parallel Conjunctival Folds
Conditions
Brief summary
The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or persists after the continued usage or discontinuation of contact lenses or refitting with low coefficient of friction lenses.
Interventions
DEVICESpectacle Lens
Spectacle Lens Only
DEVICEHabitual Soft Contact Lens
subject's own contact lens
DEVICETest Lens
senofilcon A or narafilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand and sign the statement of informed consent and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be 18 years old. 4. The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye. 5. The subject's refractive cylinder must be less than 1.50D in each eye. 6. The subject must have best visual acuity of 20/40 or better in each eye. 7. The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses. 8. The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear. 9. The subject must have normal eyes (i.e. no ocular medications or infections of any type). 10. The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS.
Exclusion criteria
1. Currently self reported pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery. 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. 5. Any previous, or planned ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) 6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection)on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other abnormality that may contraindicate contact lens wear. 7. Any ocular infection. 8. Monovision or multi-focal contact lens correction. 9. Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment. 10. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report). 11. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician) 12. Contact lens wearing of OASYS or TruEye lenses 13. Contact lens wearing time less than 6h/day and/or 5 days/week 14. Extended wear of contact lenses. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lid-Parallel Conjunctival Folds (LIPCOF) | Baseline, 2-, 4-, 8- and 12-Week Follow-up | 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). |
Countries
Germany
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spectacles Consists of subjects that were randomized to wear spectacles throughout the duration of the study. | 10 |
| 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. | 10 |
| 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). | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Spectacles | Habitual Soft Contact Lens | Senofilcon A or Narafilcon A | Total |
|---|---|---|---|---|
| Age, Continuous | 35.40 years STANDARD_DEVIATION 10.013 | 33.60 years STANDARD_DEVIATION 11.918 | 29.0 years STANDARD_DEVIATION 9.821 | 32.67 years STANDARD_DEVIATION 10.613 |
| Race/Ethnicity, Customized White | 10 participants | 10 participants | 10 participants | 30 participants |
| Region of Enrollment Germany | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Lid-Parallel Conjunctival Folds (LIPCOF)
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spectacles | Lid-Parallel Conjunctival Folds (LIPCOF) | Baseline | 1.95 Score | Standard Deviation 1.05 |
| Spectacles | Lid-Parallel Conjunctival Folds (LIPCOF) | 8-Week Follow-up | 1.50 Score | Standard Deviation 0.946 |
| Spectacles | Lid-Parallel Conjunctival Folds (LIPCOF) | 4-Week Follow-up | 1.30 Score | Standard Deviation 1.455 |
| Spectacles | Lid-Parallel Conjunctival Folds (LIPCOF) | 12- Week Follow-up | 1.35 Score | Standard Deviation 0.933 |
| Spectacles | Lid-Parallel Conjunctival Folds (LIPCOF) | 2-Week Follow-up | 1.40 Score | Standard Deviation 1.353 |
| Habitual Soft Contact Lens | Lid-Parallel Conjunctival Folds (LIPCOF) | 8-Week Follow-up | 2.15 Score | Standard Deviation 1.309 |
| Habitual Soft Contact Lens | Lid-Parallel Conjunctival Folds (LIPCOF) | Baseline | 1.75 Score | Standard Deviation 1.07 |
| Habitual Soft Contact Lens | Lid-Parallel Conjunctival Folds (LIPCOF) | 2-Week Follow-up | 2.25 Score | Standard Deviation 1.02 |
| Habitual Soft Contact Lens | Lid-Parallel Conjunctival Folds (LIPCOF) | 4-Week Follow-up | 1.95 Score | Standard Deviation 0.826 |
| Habitual Soft Contact Lens | Lid-Parallel Conjunctival Folds (LIPCOF) | 12- Week Follow-up | 2.15 Score | Standard Deviation 1.137 |
| Senofilcon A or Narafilcon A | Lid-Parallel Conjunctival Folds (LIPCOF) | 2-Week Follow-up | 1.55 Score | Standard Deviation 1.276 |
| Senofilcon A or Narafilcon A | Lid-Parallel Conjunctival Folds (LIPCOF) | 8-Week Follow-up | 1.10 Score | Standard Deviation 1.071 |
| Senofilcon A or Narafilcon A | Lid-Parallel Conjunctival Folds (LIPCOF) | Baseline | 1.70 Score | Standard Deviation 0.923 |
| Senofilcon A or Narafilcon A | Lid-Parallel Conjunctival Folds (LIPCOF) | 12- Week Follow-up | 1.00 Score | Standard Deviation 0.795 |
| Senofilcon A or Narafilcon A | Lid-Parallel Conjunctival Folds (LIPCOF) | 4-Week Follow-up | 1.05 Score | Standard Deviation 1.099 |