Clinical trial NCT03050125: The Impact of Hypo-osmolar Drops on Contact Lens Comfort
Official title: The Impact of Hypo-osmolar Drops on Contact Lens Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Related Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: CooperVision, Inc.
First posted: 2017-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study will investigate the impact of sterile saline drops that are formulated at hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of symptomatic CL wearers.


Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age;
* Has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day;
* Currently wears daily, soft, frequent replacement lenses licensed in Canada (daily, bi-weekly or monthly disposable lenses, no extended wear, no monovision) for at least 3 days/week and 6 hours/day during the 2 months prior to enrolment;
* Is symptomatic according to the following classification:

  * Reports a difference between average and comfortable wear time with habitual lenses of at least 3 hours;
  * Fall into the symptomatic group as per Young's criteria (Appendix 4).
* Is able to remove and insert the lenses by themselves;
* Owns a wearable pair of spectacles;
* Is willing to wear the study lenses for 10 hours;
* Has visual acuity (VA) correctable to logMAR 0.20 or better in each eye;
* Shows an acceptable lens fit with their habitual lenses;

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/ or infection;
* Has any ocular abnormality that would contraindicate contact lens wear;
* Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures;
* Is using any systemic or topical medications that in the option of the investigator may affect the study measures;
* Has any known sensitivity to the diagnostic pharmaceuticals and products to be used in this study;
* Is pregnant or lactating (by verbal communication) due to potential ocular physiology changes that may affect the study outcome;
* Is aphakic;
* Has undergone refractive error surgery;
* Is a member of the CCLR directly involved in the data collection. \*For the purpose of this study, active ocular disease is defined as an infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered an active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Primary outcomes:
measure: Participant's Subjective Rating of Comfort (Questionnaire)
timeFrame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
measure: Participant's Subjective Rating of Dryness (Questionnaire)
timeFrame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
measure: Participant's Subjective Rating of Foreign Body Sensation (Questionnaire)
timeFrame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
measure: Participant's Subjective Rating of Stability of Vision (Questionnaire)
timeFrame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
measure: Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale
timeFrame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
measure: Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale
timeFrame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
measure: Participant's Subjective Rating of Burning (Questionnaire) - Likert scale
timeFrame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
measure: Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale
timeFrame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
measure: Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale
timeFrame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
measure: Drop preference (compared with last drop used)
timeFrame: End of day 2, End of day 3
Secondary outcomes:
measure: Tear film osmolarity
timeFrame: Baseline, End of 1 day
measure: Tear meniscus height
timeFrame: Baseline, End of 1 day
measure: Non-invasive tear film break-up time (NITBUT)
timeFrame: Baseline, End of 1 day
measure: Conjunctival hyperemia
timeFrame: Baseline, 4.5 hrs, End of 1 Day
measure: Limbal hyperemia
timeFrame: Baseline, 4.5 hrs, End of 1 Day
measure: Average corneal staining
timeFrame: Baseline, 4.5 hrs, End of 1 Day
measure: Lens movement
timeFrame: Baseline, 4.5 hrs, End of 1 Day
measure: Lens lag
timeFrame: Baseline, 4.5 hrs, End of 1 Day
measure: Lens Tightness
timeFrame: Baseline, 4.5 hrs, End of 1 Day
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
References: