Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

Not Applicable

Completed

• Conditions: Conjunctival Staining
• Interventions: Device: ReNu MultiPlus; Device: Complete Easy Rub; Device: Clear Care; Device: Contact lenses

• Registration Number: NCT00799422
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-27
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-10-16
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-14
• Last Update Submitted: 2012-11-14
• Results First Posted: 2012-11-16
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• 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;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ReNu MultiPlus	ReNu MultiPlus	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.
ReNu MultiPlus	Contact lenses	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.
Complete Easy Rub	Complete Easy Rub	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.
Complete Easy Rub	Contact lenses	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.
Clear Care	Clear Care	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.
Clear Care	Contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Mean Circumlimbal Conjunctival Staining Score	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week	Dispense (Day 0), 1 week	Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.
Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week	Dispense (Day 0), 1 week	Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States