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N/A Completed N=54 Randomized Single-blind Treatment

2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

Visual Acuity
Source: ClinicalTrials.gov NCT02394808 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Subjective Overall Comfort — 58.65; 59.44 units on a scale

Summary

The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Overall Comfort
58.65; 59.44 —
PRIMARY
Subjective Overall Quality of Vision
55.60; 58.71 —

Eligibility Criteria

Inclusion Criteria

  • The subject must read, understand English, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be 18 and less than 40 years of age.
  • The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
  • The subject must have less than -1.00 D of cylindrical refraction.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must have normal eyes.

Exclusion Criteria

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  • Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  • Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  • Any ocular infections
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report.
  • Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02394808). 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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