N/A
N=29
Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Myopia · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01482312 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Tear Osmolarity — 310; 313; 306 mOsms/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lotrafilcon A contact lenses (Device); comfilcon A contact lenses (Device); Glasses (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Osmolarity |
310; 313; 306 | — |
| PRIMARY Ocular Comfort |
9.4; 8.2; 9.7 | — |
Summary
The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70.
- History of end-of-day or low-humidity dryness with contact lenses.
- Healthy eyes.
- Best-corrected visual acuity of 20/50 or better for each eye.
- Usable pair of eye glasses.
- Willing and able to attend required study visits.
- Sign informed consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Clinically significant ocular findings which would contraindicate contact lens wear.
- Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
- Participation in another clinical study currently or within 30 days of study entry.
- Spectacle astigmatism of >1.00 diopter.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01482312). 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.