Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

Contact Lens Related Dry Eye Clinical Trial

Official title:

A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995189
• Other study ID #: M-09-03 / DRYS 1302 / IBIS
• Status: Completed
• Phase: N/A
• First received: October 14, 2009
• Last updated: November 15, 2016
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Related Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Opti-Free RepleniSH
Contact lens care solution containing polyquaternium-1 (PQT)
• ReNu MultiPlus
Contact lens care solution containing polyhexamethylene biguanide (PHMB)
• Contact lenses
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

G. Young et al. / Contact Lens & Anterior Eye 34 (2011) 64-70 65 and Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Dryness		2 weeks, one month	No
Secondary	corneal staining		2 weeks, one month	Yes
Secondary	conjunctival staining		two weeks, one month	Yes