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N/A Completed N=97 Randomized Single-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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