Longitudinal Evaluation of Silicone Hydrogel (LASH) Study

• Sponsor: National Eye Institute (NEI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00727402
• Collaborator: (none)
• Enrollment: 205
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH) contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted patients with minimal or no astigmatism and no contraindications to CW lens use will be followed for 1 year. The primary outcome measure is the time to development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is corneal staining. Other key exploratory variables include bacterial contamination of study lenses and inflammatory mediators found in the tear film.

Condition or Disease	Intervention/Treatment	Phase
Corneal Infiltrates

Study Design

• Study Type: Observational
• Actual Enrollment: 205 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Observational healthy patients fit into lotrafilcon A contact lenses for continuous wear

Outcome Measures

Primary Outcome Measures

1. Cumulative Incidence of Corneal Inflammatory Events [annual]

   Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The patient must be at least 15 years old. Children younger than this may not be mature enough for CW, and may have difficulty following the strict instructions required for CW or sitting through the exam procedures.

2. The patient must have clear central corneas and free of any anterior segment disorders.

3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder. The parameters of the Ciba Vision Night and Day Lenses range from +6.00 to -10.00 D, and can correct the refractive range of this population. Monovision correction will be allowed only if the near eye does not exceed +6.00 D.

4. The patient must be correctable to 20/25 or better with spectacles. Amblyopia will be excluded.

5. Flat and steep corneal curvatures from SimK readings must be between 39.00 and 48.00

1. Corneal curvatures outside this range may be indicative of a disease state, and patients are not expected to comfortably wear either the 8.4 mm or 8.6 mm base curve available in Night and Day.(Dumbleton K 2002)

1. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria:

1. The patient has worn rigid gas permeable lenses within the last 30 days or PMMA lenses within the last 3 months. These lenses can transiently alter the corneal shape and influence the fitting of soft lenses.

2. The patient must not be a current extended wear user of lotrafilcon A lenses.

3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.

4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology.

5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.

6. The patient is taking any ocular medications.

7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to CW.

8. The patient is pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• National Eye Institute (NEI)

Investigators

• Principal Investigator: Loretta B Szczotka-Flynn, OD, MS, Case Western Reserve University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loretta Szczotka-Flynn, Professor, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT00727402
• Other Study ID Numbers: K23EY015270-01
• First Posted: Aug 4, 2008
• Last Update Posted: Feb 15, 2012
• Last Verified: Feb 1, 2012

Study Results

Participant Flow

Arm/Group Title	Observational
Arm/Group Description	healthy patients fit into lotrafilcon A contact lenses for continuous wear
Period Title: Overall Study
STARTED	205
COMPLETED	89
NOT COMPLETED	116

Baseline Characteristics

Arm/Group Title	Observational
Arm/Group Description	healthy patients fit into lotrafilcon A contact lenses for continuous wear
Overall Participants	205
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (5)
Age, Customized (participants) [Number]
<=21 years	26 12.7%
Between 21 and 50 years	163 79.5%
>50 years	16 7.8%
Sex: Female, Male (Count of Participants)
Female	157 76.6%
Male	48 23.4%
Region of Enrollment (participants) [Number]
United States	205 100%

Outcome Measures

1. Primary Outcome

Title	Cumulative Incidence of Corneal Inflammatory Events
Description	Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.
Time Frame	annual

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational
Arm/Group Description	healthy patients fit into lotrafilcon A contact lenses for continuous wear
Measure Participants	205
Measure eyes	410
Mean (95% Confidence Interval) [annual incidence per 100 subjects]	26.7

Adverse Events

Arm/Group Title	Observational
Arm/Group Description	healthy patients fit into lotrafilcon A contact lenses for continuous wear
All Cause Mortality
	Observational
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	0/205 (0%)
Other (Not Including Serious) Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	58/205 (28.3%)
Eye disorders
corneal inflammatory event	38/205 (18.5%)	44
Other non-Corneal Inflammatory Event	20/205 (9.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.