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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
History of Changes
  Purpose

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


Condition Intervention
Contact Lens Related Dry Eye
 Device: Opti-Free RepleniSH
Device: ReNu MultiPlus
Device: Contact lenses

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective Dryness [ Time Frame: 2 weeks, one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 159
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFR
Opti-Free RepleniSH contact lens care solution used for 30 days
 Device: Opti-Free RepleniSH
Contact lens care solution containing polyquaternium-1 (PQT)
Device: Contact lenses
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Active Comparator: RNM
ReNu MultiPlus contact lens care solution used for 30 days
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995189

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00995189     History of Changes
Other Study ID Numbers: M-09-03 / DRYS 1302 / IBIS
Study First Received: October 14, 2009
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
contact lens wear
multi-purpose solution
corneal staining

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 21, 2013