Contact Lens Adaptation in Neophytes

NCT02148263 | Completed Results

• 2 other identifiers: 2014H0074K08EY023264
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contact Lens Comfort

Keywords

Contact Lenses; Neophytes; Contact Lens Adaptation; Randomized

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart

  2 weeks

• Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)

  2 Weeks

• Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)

  2 Weeks

• Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M

  2 Weeks

• Between-Group Difference in Upper and Lower Eyelid Blepharitis

  2 Weeks

Study Arms (2)

Full-Time Senofilcon A Contact Lens Wear

EXPERIMENTAL

This group will start wearing contact lenses 8 or more hours per day on the first day of wear

Device: senofilcon A

Graduated Senofilcon A Contact Lens Wear

EXPERIMENTAL

This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).

Device: senofilcon A

Interventions

senofilcon A DEVICE

Also known as: Acuvue Oasys

Full-Time Senofilcon A Contact Lens Wear; Graduated Senofilcon A Contact Lens Wear

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (9)

• 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.

  PMID: 20631232 BACKGROUND

• Sullivan BD, Crews LA, Sonmez 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.

  PMID: 22475641 BACKGROUND

• 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. doi: 10.1097/00003226-200310000-00008.

  PMID: 14508260 BACKGROUND

• 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.

  PMID: 22775005 BACKGROUND

• 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.

  PMID: 21948646 BACKGROUND

• 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. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31.

  PMID: 16448840 BACKGROUND

• 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. doi: 10.1097/00006324-199105000-00010.

  PMID: 1852401 BACKGROUND

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

  PMID: 11220037 BACKGROUND

• Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.

  PMID: 33771956 DERIVED

Limitations and Caveats

There was a data collection error, which prevented the study from analyzing CLDEQ-8 scores. This study also intended to included conjunctival staining with lissamine green; however, lissamine green was not available during the conduct of this study, so this outcome was not included.

Results Point of Contact

• Title: Dr. Andrew Pucker
• Organization: The University of Alabama at Birmingham

apucker@uab.edu

920-579-2900

Study Officials

• Andrew D Pucker, OD, MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Jeffrey J Walline, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: August 20, 2019
• Study Completion: September 3, 2019
• Last Updated: September 29, 2022
• Results First Posted: August 22, 2022

Record last verified: 2022-09

Locations

US (1)