Trial Outcomes & Findings for Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers (NCT NCT06382064)

NCT ID: NCT06382064

Last Updated: 2025-10-20

Results Overview

Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

71 participants

Primary outcome timeframe

After 2 weeks of wear in the 1-week replacement reusable lenses.

Results posted on

2025-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Contact Lens Wear Experience Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks. Biweekly replacement contact lenses: Biweekly replacement reusable contact lenses. One week replacement contact lenses: One week replacement reusable contact lenses.
Overall Study STARTED	71
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contact Lens Wear Experience n=62 Participants Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks. Biweekly replacement contact lenses: Biweekly replacement reusable contact lenses. One week replacement contact lenses: One week replacement reusable contact lenses.
Age, Continuous	28.9 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 2 weeks of wear in the 1-week replacement reusable lenses.

Outcome measures

Outcome measures
Measure	Contact Lens Wear Experience n=62 Participants Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks. Biweekly replacement contact lenses: Biweekly replacement reusable contact lenses. One week replacement contact lenses: One week replacement reusable contact lenses.
Subjective Assessment of Lens Wear Experience	10 Scores on a scale Interval 6.0 to 16.0

Adverse Events

Contact Lens Wear Experience

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Fogt

The Ohio State University College of Optometry

Phone: 614-292-0882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place