Contact Lens Adaptation in Neophytes (CLAN)
19 september 2022 uppdaterad av: Andrew Pucker, Ohio State University
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
8 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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Andra namn:
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Experimentell: 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).
|
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
Tidsram: 2 weeks
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
Tidsram: 2 weeks
|
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
|
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Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Tidsram: 2 Weeks
|
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.
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2 Weeks
|
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Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Tidsram: 2 Weeks
|
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
|
|
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Tidsram: 2 Weeks
|
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.
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2 Weeks
|
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Between-Group Difference in Upper and Lower Eyelid Blepharitis
Tidsram: 2 Weeks
|
A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
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2 Weeks
|
|
Between-Group Difference in Corneal Sodium Fluorescein Staining
Tidsram: 2 Weeks
|
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.
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2 Weeks
|
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Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Tidsram: 2 Weeks
|
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.
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2 Weeks
|
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Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
Tidsram: 2 Weeks
|
End of day contact lens comfort was measured with a visual analog scale (1-100 scale).
Higher scores indicate better comfort.
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2 Weeks
|
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Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
Tidsram: 2-Weeks
|
Contact lens comfort was measured with a scale (1-37 scale).
Lower scores indicate better comfort.
|
2-Weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Andrew D Pucker, OD, MS, Ohio State University
- Huvudutredare: Jeffrey J Walline, OD, PhD, Ohio State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2014
Primärt slutförande (Faktisk)
20 augusti 2019
Avslutad studie (Faktisk)
3 september 2019
Studieregistreringsdatum
Först inskickad
21 maj 2014
Först inskickad som uppfyllde QC-kriterierna
22 maj 2014
Första postat (Uppskatta)
28 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 september 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 september 2022
Senast verifierad
1 september 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2014H0074
- K08EY023264 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .