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N/A Completed N=61 Randomized Single-blind Treatment

Comparative Study of Two Marketed Spherical Soft Contact Lenses

Source: ClinicalTrials.gov NCT01582789 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Comfort - First Intervention — 9.3; 9.3; 9.4; 9.3 units on a scale

Summary

The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort - First Intervention
8.5; 8.3; 7.2; 7.7; 7.7; 7.7 —
PRIMARY
Comfort - Second Intervention
8.5; 8.4; 6.3; 7.1; 7.4; 7.3 —
PRIMARY
Comfortable Wearing Time - First Intervention
11.5; 10.7 —
PRIMARY
Comfortable Wearing Time - Second Intervention
10.1; 11 —

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Based on his/her knowledge, must be in good general health.
  • Be 18 to 38 years old.
  • Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
  • Read, indicate understanding of, and sign Written Informed Consent.
  • Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
  • Require a visual correction in both eyes.
  • Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
  • Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
  • Must be able to wear their lenses at least 10 working days over the next 2-weeks; > 8 hours/day assuming there are no contraindications for doing so.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

  • Greater than 0.50D of refractive astigmatism in either eye.
  • Presbyopic or current monovision contact lens wear.
  • Cannot be currently wearing of either lenses (Avaira or Oasys)
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings; pterygium, pinguecula or corneal scars within the visual axis; neovascularization > 0.75 mm in from the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
  • A known history of corneal hypoesthesia (reduced corneal sensitivity).
  • Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
  • Aphakia, Keratoconus or a highly irregular cornea

To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01582789). 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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