Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00995189
First received: October 14, 2009
Last updated: October 19, 2012
Last verified: March 2012

October 14, 2009
October 19, 2012
August 2009
April 2010   (final data collection date for primary outcome measure)
Subjective Dryness [ Time Frame: 2 weeks, one month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995189 on ClinicalTrials.gov Archive Site
  • corneal staining [ Time Frame: 2 weeks, one month ] [ Designated as safety issue: Yes ]
  • conjunctival staining [ Time Frame: two weeks, one month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye

The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Contact Lens Related Dry Eye
  • Device: Opti-Free RepleniSH
    Contact lens care solution containing polyquaternium-1 (PQT)
  • Device: ReNu MultiPlus
    Contact lens care solution containing polyhexamethylene biguanide (PHMB)
    Other Name: ReNu MultiPlus
  • Device: Contact lenses
    Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
  • Experimental: OFR
    Opti-Free RepleniSH contact lens care solution used for 30 days
    Interventions:
    • Device: Opti-Free RepleniSH
    • Device: Contact lenses
  • Active Comparator: RNM
    ReNu MultiPlus contact lens care solution used for 30 days
    Interventions:
    • Device: ReNu MultiPlus
    • Device: Contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Reports late-day dryness symptoms with contact lens wear on questionnaire.
  • Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
  • Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Wears daily disposable contact lenses.
  • Has significant symptoms related to lens fit or lens deposits.
  • Requires concurrent ocular medication (rewetting drops allowed).
  • Has used Restasis® in the last 3 months.
  • Wears punctal plugs fitted in the last 30 days.
  • Has any current systemic or ocular abnormality, infection or disease.
  • Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
  • Has a history of refractive surgery.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995189
M-09-03 / DRYS 1302 / IBIS
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP