Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Glaucoma Clinical Trial

Official title:

Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04676126
• Other study ID #: 20-11-005
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2021
• Est. completion date: May 2022

Study information

• Verified date: September 2022
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.

Description:

This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
• Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
• Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
• Refractive error = 10 diopters and astigmatism = 3 diopters

Exclusion Criteria:

• BCVA worse than 20/200
• Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
• Loss of IOP control requires surgical intervention
• Patient already taking AREDS formula oral supplement
• Patient taking medication or dietary supplements that may interact with LM ingredients
• History of photosensitive epilepsy
• History of penetrating ocular trauma or vitrectomy
• History of ocular or orbital radiation therapy or is currently receiving chemotherapy
• Women who are nursing, pregnant, or are planning pregnancy
• Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
• Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
• Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment
• Native lens opacity = grade 3 on ARLNS standard photograph
• Blue light filter intraocular lens

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye
• Glaucoma, Open-Angle

Intervention

Dietary Supplement:
• Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin

Drug:
• Dorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor

Other:
• Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

Locations

Country	Name	City	State
United States	Ophtalmology Clinic of William E Sponsel	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of the Incarnate Word	Guardion Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (30)

Age-Related Eye Disease Study 2 (AREDS2) Research Group, Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agrón E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376. — View Citation

Akuffo KO, Beatty S, Peto T, Stack J, Stringham J, Kelly D, Leung I, Corcoran L, Nolan JM. The Impact of Supplemental Antioxidants on Visual Function in Nonadvanced Age-Related Macular Degeneration: A Head-to-Head Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Oct 1;58(12):5347-5360. doi: 10.1167/iovs.16-21192. — View Citation

Aronow ME, Chew EY. Age-related Eye Disease Study 2: perspectives, recommendations, and unanswered questions. Curr Opin Ophthalmol. 2014 May;25(3):186-90. doi: 10.1097/ICU.0000000000000046. Review. — View Citation

Bone RA, Davey PG, Roman BO, Evans DW. Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response. Nutrients. 2020 May 6;12(5). pii: E1321. doi: 10.3390/nu12051321. — View Citation

Bone RA, Landrum JT, Hime GW, Cains A, Zamor J. Stereochemistry of the human macular carotenoids. Invest Ophthalmol Vis Sci. 1993 May;34(6):2033-40. — View Citation

Britton G. Structure and properties of carotenoids in relation to function. FASEB J. 1995 Dec;9(15):1551-8. Review. — View Citation

Chew EY, Clemons TE, Agrón E, Sperduto RD, Sangiovanni JP, Kurinij N, Davis MD; Age-Related Eye Disease Study Research Group. Long-term effects of vitamins C and E, ß-carotene, and zinc on age-related macular degeneration: AREDS report no. 35. Ophthalmology. 2013 Aug;120(8):1604-11.e4. doi: 10.1016/j.ophtha.2013.01.021. Epub 2013 Apr 10. Erratum in: Ophthalmology. 2016 Dec;123(12 ):2634. — View Citation

Conrady CD, Bell JP, Besch BM, Gorusupudi A, Farnsworth K, Ermakov I, Sharifzadeh M, Ermakova M, Gellermann W, Bernstein PS. Correlations Between Macular, Skin, and Serum Carotenoids. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3616-3627. doi: 10.1167/iovs.17-21818. — View Citation

Ermakov IV, Gellermann W. Dermal carotenoid measurements via pressure mediated reflection spectroscopy. J Biophotonics. 2012 Jul;5(7):559-70. doi: 10.1002/jbio.201100122. Epub 2012 Feb 13. — View Citation

Eysteinsson T, Gudmundsdottir H, Hardarson AO, Berrino E, Selleri S, Supuran CT, Carta F. Carbonic Anhydrase Inhibitors of Different Structures Dilate Pre-Contracted Porcine Retinal Arteries. Int J Mol Sci. 2019 Jan 22;20(3). pii: E467. doi: 10.3390/ijms20030467. — View Citation

Foote CS, Chang YC, Denny RW. Chemistry of singlet oxygen. X. Carotenoid quenching parallels biological protection. J Am Chem Soc. 1970 Aug 26;92(17):5216-8. — View Citation

Greco A, Rizzo MI, De Virgilio A, Gallo A, Fusconi M, de Vincentiis M. Emerging Concepts in Glaucoma and Review of the Literature. Am J Med. 2016 Sep;129(9):1000.e7-1000.e13. doi: 10.1016/j.amjmed.2016.03.038. Epub 2016 Apr 26. Review. — View Citation

Hammond BR Jr, Fuld K. Interocular differences in macular pigment density. Invest Ophthalmol Vis Sci. 1992 Feb;33(2):350-5. — View Citation

Jahns L, Johnson LK, Conrad Z, Bukowski M, Raatz SK, Jilcott Pitts S, Wang Y, Ermakov IV, Gellermann W. Concurrent validity of skin carotenoid status as a concentration biomarker of vegetable and fruit intake compared to multiple 24-h recalls and plasma carotenoid concentrations across one year: a cohort study. Nutr J. 2019 Nov 21;18(1):78. doi: 10.1186/s12937-019-0500-0. — View Citation

Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9. — View Citation

Katz LJ, Simmons ST, Craven ER. Efficacy and safety of brimonidine and dorzolamide for intraocular pressure lowering in glaucoma and ocular hypertension. Curr Med Res Opin. 2007 Dec;23(12):2971-83. Review. — View Citation

Knox DL, Eagle RC Jr, Green WR. Optic nerve hydropic axonal degeneration and blocked retrograde axoplasmic transport: histopathologic features in human high-pressure secondary glaucoma. Arch Ophthalmol. 2007 Mar;125(3):347-53. — View Citation

Ma L, Liu R, Du JH, Liu T, Wu SS, Liu XH. Lutein, Zeaxanthin and Meso-zeaxanthin Supplementation Associated with Macular Pigment Optical Density. Nutrients. 2016 Jul 12;8(7). pii: E426. doi: 10.3390/nu8070426. Review. — View Citation

Mayne ST, Cartmel B, Scarmo S, Jahns L, Ermakov IV, Gellermann W. Resonance Raman spectroscopic evaluation of skin carotenoids as a biomarker of carotenoid status for human studies. Arch Biochem Biophys. 2013 Nov 15;539(2):163-70. doi: 10.1016/j.abb.2013.06.007. Epub 2013 Jun 30. Review. — View Citation

Nakano Y, Hirooka K, Chiba Y, Ueno M, Ojima D, Hossain MR, Takahashi H, Yamamoto T, Kiuchi Y. Retinal ganglion cell loss in kinesin-1 cargo Alcadein a deficient mice. Cell Death Dis. 2020 Mar 3;11(3):166. doi: 10.1038/s41419-020-2363-x. — View Citation

Obana A, Tanito M, Gohto Y, Okazaki S, Gellermann W, Bernstein PS. Changes in Macular Pigment Optical Density and Serum Lutein Concentration in Japanese Subjects Taking Two Different Lutein Supplements. PLoS One. 2015 Oct 9;10(10):e0139257. doi: 10.1371/journal.pone.0139257. eCollection 2015. — View Citation

Padmanaban V, Inati S, Ksendzovsky A, Zaghloul K. Clinical advances in photosensitive epilepsy. Brain Res. 2019 Jan 15;1703:18-25. doi: 10.1016/j.brainres.2018.07.025. Epub 2018 Aug 1. Review. — View Citation

Pinazo-Durán MD, Zanón-Moreno V, Gallego-Pinazo R, García-Medina JJ. Oxidative stress and mitochondrial failure in the pathogenesis of glaucoma neurodegeneration. Prog Brain Res. 2015;220:127-53. doi: 10.1016/bs.pbr.2015.06.001. Epub 2015 Sep 8. Review. — View Citation

Power R, Coen RF, Beatty S, Mulcahy R, Moran R, Stack J, Howard AN, Nolan JM. Supplemental Retinal Carotenoids Enhance Memory in Healthy Individuals with Low Levels of Macular Pigment in A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Alzheimers Dis. 2018;61(3):947-961. doi: 10.3233/JAD-170713. — View Citation

Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30. Review. — View Citation

Remky A, Weber A, Arend O, Sponsel WE. Topical dorzolamide increases pericentral visual function in age-related maculopathy: pilot study findings with short-wavelength automated perimetry. Acta Ophthalmol Scand. 2005 Apr;83(2):154-60. — View Citation

Schmidl D, Schmetterer L, Garhöfer G, Popa-Cherecheanu A. Pharmacotherapy of glaucoma. J Ocul Pharmacol Ther. 2015 Mar;31(2):63-77. doi: 10.1089/jop.2014.0067. Epub 2015 Jan 14. Review. — View Citation

Sponsel WE, Harrison J, Elliott WR, Trigo Y, Kavanagh J, Harris A. Dorzolamide hydrochloride and visual function in normal eyes. Am J Ophthalmol. 1997 Jun;123(6):759-66. — View Citation

Tsai T, Reinehr S, Maliha AM, Joachim SC. Immune Mediated Degeneration and Possible Protection in Glaucoma. Front Neurosci. 2019 Sep 2;13:931. doi: 10.3389/fnins.2019.00931. eCollection 2019. Review. — View Citation

Wax MB. The case for autoimmunity in glaucoma. Exp Eye Res. 2011 Aug;93(2):187-90. doi: 10.1016/j.exer.2010.08.016. Epub 2010 Aug 27. Review. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pericentral Visual Function	Mean deviation and pattern standard deviation of 10-2 Humphrey visual field	3 Months
Secondary	Macular Pigment Optical Density	Macular Pigment Optical Density measured by Mapcat SF	Monthly for 3 months
Secondary	Dermal Carotenoid Levels	Measured by Veggie Meter	Monthly for 3 months
Secondary	Contrast Sensitivity	Measured by Vector Vision CSV-2000	Monthly for 3 months