Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

NCT00799422 | Completed Results

• 1 other identifier: M-08-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

Conditions

Conjunctival Staining

Keywords

Conjunctival Staining; lens parameters; lens fit

Outcome Measures

Primary Outcomes (1)

• Mean Circumlimbal Conjunctival Staining Score

  Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.

  1 week

Secondary Outcomes (2)

• Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week

  Dispense (Day 0), 1 week

• Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week

  Dispense (Day 0), 1 week

Study Arms (3)

ReNu MultiPlus

ACTIVE COMPARATOR

ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Device: ReNu MultiPlus; Device: Contact lenses

Complete Easy Rub

ACTIVE COMPARATOR

Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Device: Complete Easy Rub; Device: Contact lenses

Clear Care

ACTIVE COMPARATOR

Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Device: Clear Care; Device: Contact lenses

Interventions

Complete Easy Rub DEVICE

Commercially marketed contact lens solution for contact lens care

Also known as: Complete® Easy Rub®

Complete Easy Rub

ReNu MultiPlus DEVICE

Commercially marketed contact lens solution for contact lens care

Also known as: ReNu MultiPlus®

ReNu MultiPlus

Clear Care DEVICE

Commercially marketed contact lens solution for contact lens care

Also known as: Clear Care®

Clear Care

Contact lenses DEVICE

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Also known as: ACUVUE® OASYS®

Clear Care; Complete Easy Rub; ReNu MultiPlus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
• Read, sign, and date informed consent/HIPAA document;
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
• Willing and able to discontinue contact lens wear when requested during the study;

You may not qualify if:

• Evidence or history of ocular disease or pathology;
• One functional eye or a monofit lens;
• Use of concomitant topical ocular prescription or over-the-counter ocular medications;
• History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

Contact Lenses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Head, Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

1-888-451-3937

Study Officials

• Alison Ramsey, O.D.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 27, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 16, 2012
• Results First Posted: November 16, 2012

Record last verified: 2012-11

Locations

US (1)