Cool vs Room-temperature Artificial Tears

NCT05832996 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 202201397
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort. Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.

Conditions

Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis); Central Retinal Vein Occlusion With Macular Edema; Exudative Age-Related Macular Degeneration, Unspecified Eye; Cystoid Macular Edema; Ocular Surface Disease; Dry Eye Sensation; Eye Pain

Outcome Measures

Primary Outcomes (1)

• The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.

  The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain

  with 72 hours of the intervention

Study Arms (2)

Cooled artificial tear group

EXPERIMENTAL

Stored at 4 degree Celsius

Drug: Refresh Plus Preservative-free Lubricant Eye Drops

Room temperature artificial tear group

ACTIVE COMPARATOR

Stored at 25 degree Celsius

Drug: Refresh Plus Preservative-free Lubricant Eye Drops

Interventions

Refresh Plus Preservative-free Lubricant Eye Drops DRUG

Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius

Cooled artificial tear group; Room temperature artificial tear group

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.

You may not qualify if:

• Inability or lack of willingness to participate in the study
• Active ocular infection including infectious uveitis
• First time receiving intravitreal injection
• Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
• Less than 18 years of age

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals & Clinics - Department of Ophthalmology

Iowa City, Iowa, 52242, United States

Location

Related Publications (20)

• Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01.

  PMID: 19584648 BACKGROUND

• Patel SN, Gangaputra S, Sternberg P Jr, Kim SJ. Prophylaxis measures for postinjection endophthalmitis. Surv Ophthalmol. 2020 Jul-Aug;65(4):408-420. doi: 10.1016/j.survophthal.2019.12.005. Epub 2020 Jan 7.

  PMID: 31923477 BACKGROUND

• Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437.

  PMID: 28984794 BACKGROUND

• Swift W, Bair JA, Chen W, Li M, Lie S, Li D, Yang M, Shatos MA, Hodges RR, Kolko M, Utheim TP, Scott W, Dartt DA. Povidone iodine treatment is deleterious to human ocular surface conjunctival cells in culture. BMJ Open Ophthalmol. 2020 Sep 16;5(1):e000545. doi: 10.1136/bmjophth-2020-000545. eCollection 2020.

  PMID: 32995498 BACKGROUND

• Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul Toxicol. 2017 Dec;36(4):343-346. doi: 10.1080/15569527.2017.1291665. Epub 2017 Feb 28.

  PMID: 28166657 BACKGROUND

• Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and proposed management strategies. Clin Ophthalmol. 2017 Aug 16;11:1491-1497. doi: 10.2147/OPTH.S136500. eCollection 2017.

  PMID: 28860698 BACKGROUND

• Dohlman TH, Lertsuwanroj B, D'Amico DJ, Ciralsky JB, Kiss S. Evaluation of signs and symptoms of ocular surface disease after intravitreal injection. Acta Ophthalmol. 2019 Dec;97(8):e1154-e1156. doi: 10.1111/aos.14146. Epub 2019 Jun 25. No abstract available.

  PMID: 31237739 BACKGROUND

• Segal O, Segal-Trivitz Y, Nemet AY, Cohen P, Geffen N, Mimouni M. Anxiety levels and perceived pain intensity during intravitreal injections. Acta Ophthalmol. 2016 Mar;94(2):203-4. doi: 10.1111/aos.12802. Epub 2015 Jul 28. No abstract available.

  PMID: 26215781 BACKGROUND

• Chaturvedi R, Wannamaker KW, Riviere PJ, Khanani AM, Wykoff CC, Chao DL. Real-World Trends in Intravitreal Injection Practices among American Retina Specialists. Ophthalmol Retina. 2019 Aug;3(8):656-662. doi: 10.1016/j.oret.2019.03.023. Epub 2019 Apr 4.

  PMID: 31133544 BACKGROUND

• Avery RL, Bakri SJ, Blumenkranz MS, Brucker AJ, Cunningham ET Jr, D'Amico DJ, Dugel PU, Flynn HW Jr, Freund KB, Haller JA, Jumper JM, Liebmann JM, McCannel CA, Mieler WF, Ta CN, Williams GA. Intravitreal injection technique and monitoring: updated guidelines of an expert panel. Retina. 2014 Dec;34 Suppl 12:S1-S18. doi: 10.1097/IAE.0000000000000399.

  PMID: 25489719 BACKGROUND

• Kaplan RI, Drinkwater OJ, Lee RH, Chod RB, Barash A, Giovinazzo JV, Gologorsky D, Jansen ME, Rosen RB, Gentile RC. Pain Control after Intravitreal Injection Using Topical Nepafenac 0.3% or Pressure Patching: A Randomized, Placebo-Controlled Trial. Ophthalmol Retina. 2019 Oct;3(10):860-866. doi: 10.1016/j.oret.2019.04.022. Epub 2019 Apr 26.

  PMID: 31221565 BACKGROUND

• Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.

  PMID: 22562296 BACKGROUND

• Gaynes BI, Fiscella R. Topical nonsteroidal anti-inflammatory drugs for ophthalmic use: a safety review. Drug Saf. 2002;25(4):233-50. doi: 10.2165/00002018-200225040-00002.

  PMID: 11994027 BACKGROUND

• Fujishima H, Yagi Y, Shimazaki J, Tsubota K. Effects of artificial tear temperature on corneal sensation and subjective comfort. Cornea. 1997 Nov;16(6):630-4.

  PMID: 9395871 BACKGROUND

• Hu Youwei J, Chang B. Effect of cooling proparacaine 0.5% eye drops on patient's comfort during instillation. Eye (Lond). 2015 Aug;29(8):1112-3. doi: 10.1038/eye.2015.59. Epub 2015 Apr 24. No abstract available.

  PMID: 25907208 BACKGROUND

• Ramos MS, Xu LT, Singuri S, Castillo Tafur JC, Arepalli S, Ehlers JP, Kaiser PK, Singh RP, Rachitskaya AV, Srivastava SK, Sears JE, Schachat AP, Babiuch AS, Sharma S, Martin DF, Lowder CY, Singh AD, Yuan A, Nowacki AS. Patient-Reported Complications after Intravitreal Injection and Their Predictive Factors. Ophthalmol Retina. 2021 Jul;5(7):625-632. doi: 10.1016/j.oret.2020.09.024. Epub 2020 Oct 12.

  PMID: 33059077 BACKGROUND

• Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015 Jan 30;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071.

  PMID: 25686388 BACKGROUND

• Bitton E, Crncich V, Brunet N. Does the temperature of an artificial tear affect its comfort? Clin Exp Optom. 2018 Sep;101(5):641-647. doi: 10.1111/cxo.12664. Epub 2018 Feb 18.

  PMID: 29457271 BACKGROUND

• Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database Syst Rev. 2016 Feb 23;2:CD009729. doi: 10.1002/14651858.CD009729.pub2.

  PMID: 26905373 BACKGROUND

• Walsh K, Jones L. The use of preservatives in dry eye drops. Clin Ophthalmol. 2019 Aug 1;13:1409-1425. doi: 10.2147/OPTH.S211611. eCollection 2019.

  PMID: 31447543 BACKGROUND

MeSH Terms

Conditions

Disease; Macular Edema; Eye Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Manifestations; Signs and Symptoms; Pain; Neurologic Manifestations

Results Point of Contact

• Title: Douglas Jin, MD
• Organization: University of Iowa

Douglas-Jin@uiowa.edu

319-356-3185

Study Officials

• Douglas Jin, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 27, 2023
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 6, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (1)