N/A
Completed N=60
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Contact Lens Discomfort · Dry Eye Disease · Meibomian Gland Dysfunction
Source: ClinicalTrials.gov NCT02848222 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) — 9.2; 8.5; 7.1 hours per day — p=0.02
Summary
The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) |
9.2; 8.5; 7.1 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Provide informed consent and authorization to disclose protected health information
- Have habitual contact lens corrected visual acuity in each eye of at least 20/30
- Willing to comply with protocol
- Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 days a week on average over at least a 30 day period before enrollment
Exclusion Criteria
- Have any uncontrolled systemic disease that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease
- Pregnant by self-report
- Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis
Data sourced from ClinicalTrials.gov (NCT02848222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.