Contact Lens Adaptation in Neophytes

NCT ID: NCT02148263

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-09-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Full-Time Senofilcon A Contact Lens Wear

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

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

Graduated Senofilcon A Contact Lens Wear

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).

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

Interventions

senofilcon A

Intervention Type: DEVICE

Other Intervention Names

Acuvue Oasys

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Pucker

Senior Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew D Pucker, OD, MS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Jeffrey J Walline, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20631232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22475641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14508260 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22775005 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21948646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16448840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1852401 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 11220037 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33771956 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

K08EY023264

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014H0074

Identifier Type: -

Identifier Source: org_study_id