N/A
N=37
Endothelial Bleb Response With Toric Lenses
Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT00630305 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Endothelial Bleb Areas on Cornea: Session A- Open Eye — 0.1; 2.0; 0.2; 2.1 Percent Difference of Bleb Area
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- alphafilcon A toric (Device); lotrafilcon B toric (Device); senofilcon A toric (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Bleb Areas on Cornea: Session A- Open Eye |
0.1; 2.0; 0.2; 2.1; 0.0; 0.8 | — |
| PRIMARY Endothelial Bleb Areas on Cornea: Session B- Closed Eye |
2.0; 5.9; 4.0; 0.9; 0.5; 3.9 | — |
| PRIMARY Endothelial Bleb Areas on Cornea: Session C- Open Eye |
0.2; 0.4; 0.2; 0.2; 0.1; 0.1 | — |
| PRIMARY Endothelial Bleb Areas on Cornea: Session D- Closed Eye |
1.7; 1.6; 0.5; 3.5; 0.8; 1.7 | — |
Summary
Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.
Eligibility Criteria
Inclusion Criteria
- Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
- At least 18 years of age and mentally competent to sign an informed consent form.
- Healthy eyes and no use of ocular medication.
- Similarity of optical parameters between eyes.
- Physical appearance typical of Asian eyes
Exclusion Criteria
- A medical or ocular condition that may influence the outcome of this trial.
- Current use of ocular/systemic medication that may influence the outcome of this trial.
- Failure to wear soft lenses for 2 weeks prior to the start of the study.
- Current enrolment or participation in another clinical study.
- Current state of pregnancy or breastfeeding
- Anisometropia greater than 1.00D (equivalent sphere).
- Unequal acuities between eyes (greater than 1 line)
- Unequal corneal curvatures (>1.00D)
Data sourced from ClinicalTrials.gov (NCT00630305). 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.