N/A
N=26
Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
Conjunctival Staining
Bottom Line
View on ClinicalTrials.gov: NCT00799422 ↗Enrolled (actual)
26
Serious AEs
1.5%
Results posted
Nov 2012
Primary outcome: Primary: Mean Circumlimbal Conjunctival Staining Score — 6.39; 5.55; 5.68 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Complete Easy Rub (Device); ReNu MultiPlus (Device); Clear Care (Device); Contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Circumlimbal Conjunctival Staining Score |
6.39; 5.55; 5.68 | — |
| SECONDARY Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week |
-0.25; -0.27; -0.25 | — |
| SECONDARY Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week |
0.15; 0.13; 0.14 | — |
Summary
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
Eligibility Criteria
Inclusion Criteria
- Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
- Read, sign, and date informed consent/HIPAA document;
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
- Willing and able to discontinue contact lens wear when requested during the study;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Evidence or history of ocular disease or pathology;
- One functional eye or a monofit lens;
- Use of concomitant topical ocular prescription or over-the-counter ocular medications;
- History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00799422). 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.