NCT03050125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

February 8, 2017

Last Update Submit

May 1, 2017

Conditions

Contact Lens Related Dry Eye

Outcome Measures

Primary Outcomes (10)

  • Participant's Subjective Rating of Comfort (Questionnaire)

    Participants rated their eye comfort by subjective questionnaire (un-annotated scale, 0-100, 0=Very poor comfort, 100=Excellent comfort). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day

  • Participant's Subjective Rating of Dryness (Questionnaire)

    Participants rated the dryness of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Very dry, 100=No dryness at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day

  • Participant's Subjective Rating of Foreign Body Sensation (Questionnaire)

    Participants rated the foreign body sensation of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Intense feeling of foreign body sensation, 100=No foreign body sensation at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day

  • Participant's Subjective Rating of Stability of Vision (Questionnaire)

    Participants rated the stability of their vision by subjective questionnaire (un-annotated scale, 0-100, 0=Not stable at all/ very fluctuating, 100=Very stable). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day

  • Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale

    Participants responded to the statement "My eyes feels comfortable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.

  • Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale

    Participants responded to the statement "My eyes feel dry" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.

  • Participant's Subjective Rating of Burning (Questionnaire) - Likert scale

    Participants responded to the statement "My eyes burn" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.

  • Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale

    Participants responded to the statement "I am aware of the lenses in my eyes" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.

  • Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale

    Participants responded to the statement "My vision is stable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.

    Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.

  • Drop preference (compared with last drop used)

    Participant's subjective response for drop preference (compared with last drop used) at the end of days 2 and 3. (5 possible ratings: Strongly prefer Day 1, Prefer Day 1, No preference, Prefer Day 2, Strongly prefer day 2 OR Strongly Prefer Day 2, Prefer Day 2, No preference, Prefer Day 3, Strongly prefer day 3)

    End of day 2, End of day 3

Secondary Outcomes (9)

  • Tear film osmolarity

    Baseline, End of 1 day

  • Tear meniscus height

    Baseline, End of 1 day

  • Non-invasive tear film break-up time (NITBUT)

    Baseline, End of 1 day

  • Conjunctival hyperemia

    Baseline, 4.5 hrs, End of 1 Day

  • Limbal hyperemia

    Baseline, 4.5 hrs, End of 1 Day

  • +4 more secondary outcomes

Study Arms (3)

Hypo-osmolar drop 1

EXPERIMENTAL

Subject will receive regular instillations of hypo-osmolar sterile saline drops with the lowest osmolarity of the two hypo-osmolar drops.

Device: Hypo-osmolar drop 1

Hypo-osmolar drop 2

EXPERIMENTAL

Subject will receive regular instillations of hypo-osmolar sterile saline drops with the highest osmolarity of the two hypo-osmolar drops.

Device: Hypo-osmolar drop 2

Iso-osmolar drop

EXPERIMENTAL

Subject will receive regular instillations of sterile iso-osmolar saline drops.

Device: Iso-osmolar drop

Interventions

Hypo-osmolar drop 1DEVICE

180 mOsmol sterile saline drops used as a contact lens rewetting drop.

Hypo-osmolar drop 1
Hypo-osmolar drop 2DEVICE

240 mOsmol sterile saline drops used as a contact lens rewetting drop.

Hypo-osmolar drop 2
Iso-osmolar dropDEVICE

300 mOsmol sterile saline drops used as a contact lens rewetting drop.

Iso-osmolar drop

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Centre for Contact Lens Research

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

February 7, 2017

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)