Skip to main content
OpenTrials
Completed

NCT Number: NCT03050125

The Impact of Hypo-osmolar Drops on Contact Lens Comfort

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypo-osmolar drop 1

Device

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

Hypo-osmolar drop 2

Device

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

Iso-osmolar drop

Device

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

Primary outcomes

  1. Participant's Subjective Rating of Comfort (Questionnaire)

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

    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.

  2. Participant's Subjective Rating of Dryness (Questionnaire)

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

    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.

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

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

    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.

  4. Participant's Subjective Rating of Stability of Vision (Questionnaire)

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  10. Drop preference (compared with last drop used)

    Time frame: End of day 2, End of day 3

    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)

Secondary outcomes

  1. Tear film osmolarity

    Time frame: Baseline, End of 1 day

    Tear film osmolarity in mOsmol/L, measured prior to the first drop of the day and at the end of the day.

  2. Tear meniscus height

    Time frame: Baseline, End of 1 day

    Tear meniscus height in mm, measured prior to the first drop of the day and at the end of the day.

  3. Non-invasive tear film break-up time (NITBUT)

    Time frame: Baseline, End of 1 day

    Measurement of time taken in seconds for a dry spot to appear on the corneal surface after blinking.

  4. Conjunctival hyperemia

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).

  5. Limbal hyperemia

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Limbal hyperemia evaluated on a scale from 0 (normal) to 4 (severe).

  6. Average corneal staining

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Average corneal staining evaluated on a scale from 0 (normal) to 4 (severe).

  7. Lens movement

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Amount of lens movement on blink (mm).

  8. Lens lag

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Amount of lens lag on blink (mm).

  9. Lens Tightness

    Time frame: Baseline, 4.5 hrs, End of 1 Day

    Amount of lens tightness (%).

Sponsors and collaborators

Lead sponsor

Centre for Contact Lens Research

Other

Collaborators

  • CooperVision, Inc.

Registry information

Acronym: SAFFRON

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.