Clinical Characterization of Symptomatic Populations
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 8/24/2018 |
Start Date: | September 29, 2017 |
End Date: | August 15, 2018 |
This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of
symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study
lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear
for 1 week.
symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study
lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear
for 1 week.
Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the
study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical
protocol.
3. Between 18 and 55 (inclusive) years of age at the time of screening.
4. Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week
wear time over the last 1 month by self-report.
5. Have a baseline CLDEQ-8 score of either:
1. 7 or lower
2. 15 or greater
6. Subjects must possess a functional / usable pair of spectacles and bring them to
the visit (only if applicable - to the investigators discretion).
7. Subjects must pass a pre-screening questionnaire.
8. Subjects must be willing to discontinue all contact lens wear for approximately 1
week/
9. Subjects must present to visit 1 with their habitual lenses on eye for at least 6
hours.
Exclusion Criteria:
- Potential subjects who meet any of the following criteria will be excluded from
participating in the study:
1. Currently pregnant or lactating, by self-report.
2. Any ocular or systemic allergies, disease or use of medication which may
interfere with contact lens wear (at the discretion of the investigator).
3. Any active ocular abnormalities/conditions that may interfere with contact lens
wear (at the discretion of the investigator).
4. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious
immunosuppressive disease (e.g. HIV), by self-report.
5. Any corneal distortion resulting from previous hard or rigid gas permeable
contact lens wear.
6. Habitual contact lens wear modality as extended wear (≥1 night per month of
extended wear).
7. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
8. Any previous, or planned (during the course of the study) ocular surgery (e.g.,
radial keratotomy, PRK, LASIK, etc.)
9. Participation in any contact lens or lens care product clinical trial within 2
weeks prior to study enrollment.
10. Employee or employee's immediate family member of clinical site (e.g.,
Investigator, Coordinator, Technician).
11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX
or OTC) that may interfere with contact lens wear (at the discretion of the
investigator).
We found this trial at
2
sites
200 Columbia Street West
Waterloo, Ontario N2L 3G1
Waterloo, Ontario N2L 3G1
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