N/A
Completed N=97
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
Refractive Error
Source: ClinicalTrials.gov NCT00762385 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Lens Comfort — 0.1452; 0.1135 combined score
Summary
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Comfort |
0.1452; 0.1135 | — |
| PRIMARY Comfort Symptoms |
0.2440; -0.02862 | — |
| SECONDARY Overall Corneal Staining |
0.07582; 0.07026 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
- The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
- The subject, based on his/her knowledge, must be in good general health.
- The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
- Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
- Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
- Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
- The subject must read, indicate understanding of and sign the Informed Consent Form.
Exclusion Criteria
- The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
- Slit lamp findings that would contraindicate contact lens wear such as:
- pathological dry eye or associated findings
- pterygium or corneal scars within the visual axis
- neovascularization equal to or greater than 1mm in from the limbus
- history of giant papillary conjunctivitis (GPC) worse than grade 2
- anterior uveitis or iritis (past or present)
- seborrhoeic eczema
- seborrhoeic conjunctivitis
- A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Contact lens snellen visual acuities (VA) worse than 20/30.
- Aphakia, keratoconus or a highly irregular cornea.
- Current pregnancy or lactation (to the best of the subject's knowledge)
- Any active participation in another clinical study at any time during this study.
Data sourced from ClinicalTrials.gov (NCT00762385). 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.