N/A
Completed N=37
Endothelial Bleb Response With Toric Lenses
Source: ClinicalTrials.gov NCT00630305 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Endothelial Bleb Areas on Cornea: Session A- Open Eye — 0.1; 2.0; 0.2; 2.1 Percent Difference of Bleb Area
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.
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 | — |
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. Informational only — not medical advice.