N/A
N=134
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01996709 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 — 2.3; 2.3; 2.2; 2.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrogen peroxide-based contact lens solution (Device); Habitual contact lens solution (Device); Habitual contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 |
2.3; 2.3; 2.2; 2.2; 0.9; 0.9 | — |
| SECONDARY Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90 |
52.5; 37.3 | — |
| SECONDARY Mean Frequency Score for Symptoms of Grittiness at Day 90 |
1.7; 2.3 | — |
| SECONDARY Mean Frequency Score for Symptoms of Dryness at Day 90 |
1.2; 1.8 | — |
Summary
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
Eligibility Criteria
Inclusion Criteria
- Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
- Symptoms of contact lens discomfort as defined by the protocol.
- Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
- Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Extended (over-night) contact lens wearer.
- Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01996709). 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.