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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014