Contact Lens Adaptation in Neophytes

Contact Lens Comfort Clinical Trial

— CLAN  

Official title:

Contact Lens Adaptation in Neophytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148263
• Other study ID #: 2014H0074
• Secondary ID: K08EY023264
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 3, 2019

Study information

• Verified date: September 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 3, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Has had a completed comprehensive eye exam within the past 6 months

• Able to wear spherical senofilcon A contact lenses

• Able to use Opti-Free PureMoist contact lens solution

Exclusion Criteria:

• Any prior contact lens use

• Topical eye drops within the last two hours of the study visit

• Known systemic health conditions known to alter tear film physiology

• History of severe ocular trauma

• Active ocular infection

• Active ocular inflammation

• Known hypersensitivity to diagnostic eye drops

• Pregnant or breast feeding

Related Conditions & MeSH terms

• Contact Lens Comfort

Intervention

Device:
• senofilcon A

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. Review. — View Citation

Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. Epub 2006 Jan 31. — View Citation

Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027. — View Citation

Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29. — View Citation

Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. — View Citation

Sullivan BD, Crews LA, Sönmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60. — View Citation

Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14. — View Citation

Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)	This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	2 weeks
Secondary	Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart	The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores.	2 weeks
Secondary	Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)	Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability.	2 Weeks
Secondary	Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)	Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume.	2 Weeks
Secondary	Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M	Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better.	2 Weeks
Secondary	Between-Group Difference in Upper and Lower Eyelid Blepharitis	A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.	2 Weeks
Secondary	Between-Group Difference in Corneal Sodium Fluorescein Staining	The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining.	2 Weeks
Secondary	Between-Group Difference in Tear Volume as Measured by Schirmer's Test I	Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume.	2 Weeks
Secondary	Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)	End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.	2 Weeks
Secondary	Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores	Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort.	2-Weeks