Comprehensive Study on Dry Eye and Ocular Surface Disease Prior and After Cataract Surgery

NCT04711642 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: Dry Eye and Cataract Surgery
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ocular surface disease (OSD), particularly dry eye, is one of the most common conditions seen by ophthalmologists. Dry eye (DE) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear instability. DE significantly reduces quality of life and affects 5-30% of the population. As the proportion of individuals over age 60 increases because of greater life expectancies, we can anticipate the number of people with dry eye will also increase, which represents a major challenging for aging societies, like the Chilean one. In the last few years clinical research on OSD is being intensely focused on diagnostic criteria, treatment strategies, methods used in diagnosis and better correlations between symptoms and clinical test results. All these lines of interest aim to improve the understanding of alterations and consequences occurring in the ocular surface disorders. Diagnostic testing is greatly valuable both for the detection of early changes due to DE and also to grade the severity of surface disease. The most commonly performed tests include the Schirmer test, tear break up time (TBUT), and ocular surface staining. However, newer point-of-care diagnostics tests such as tear osmolarity and matrix metalloprotease-9 (MMP-9) have been shown to have a high sensitivity and specificity in diagnosing ocular surface dysfunction. Given that ocular surface dysfunction has been shown to have an adverse impact on visual function and can worsen after surgery, it is critical to identify and address any tear film and ocular surface abnormalities before cataract surgery. In the setting of preoperative cataract surgery planning, DE disease and meibomian gland dysfunction can impair critical refractive measures such as keratometry values worsening surgical outcomes. To the best of our knowledge there are no ongoing or published studies that have evaluated DE and OSD as evidenced by either an abnormal tear-film parameter (elevated MMP-9 or abnormal osmolarity), or corneal surface and meibography evaluation findings (using novel non-invasive technology) in patients previous and after cataract surgery.

Conditions

Dry Eye Disease; Dry Eye Syndrome; Evaporative Dry Eye; Cataract; Phacoemulsification

Keywords

Cataract surgery; Dry eye disease; Ocular surface osmolarity; matrix metalloproteinase-9

Outcome Measures

Primary Outcomes (1)

• Dry eye ocular symptoms

  Difference in Ocular Surface Disease Index (OSDI) scores between groups.

  Baseline, 30 days, 90 days

Secondary Outcomes (3)

• Non-invasive Break-up time

  Baseline, 30 days, 90 days

• Tear osmolarity

  Baseline 30 days, 90 days

• InflammaDry (MMP9) test

  Baseline, 30 days, 90 days

Study Arms (3)

No intervention

NO INTERVENTION

Control group.

Treatment 1

EXPERIMENTAL

Sodium hyaluronate 0.1% eyedrops (Systane ultra plus), q.i.d from day 7 to day 30 after cataract surgery.

Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)

Treatment 2

EXPERIMENTAL

Sodium hyaluronate 0.1% eyedrops (Hylo-comod), q.i.d from day 7 to day 30 after cataract surgery.

Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)

Interventions

The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod) DRUG

All groups will receive a topical steroid-antibiotic for 3 weeks. The study groups will be also prescribed eye drops containing sodium hyaluronate 0.1% from the postoperative day 7 for 4 weeks.

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Indication of phacoemulsification for refractive purposes or for the presence of visually significant cataract.
• Absence of intraoperative or postoperative complications of phacoemulsification
• Willing to participate in the study (signed informed consent)

You may not qualify if:

• Ocular surgeries within the previous 6 months.
• Contact lenses user.
• Severe blepharitis.
• Palpebral malposition and secondary dry eye
• History of filamentary keratitis, corneal neovascularization, or herpetic keratitis within previous 3 months.
• Hypersensitivity to investigated substances or diagnostic stains used.
• Antiglaucomatous topical medication
• Artificial tears with instillation frequency greater than 3 times a day in the last week

Sponsors & Collaborators

• Fundación Oftalmológica Los Andes: lead
• Alcon Research: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Study Officials

• Luis Montecinos Buneder, MD

  Fundacion Oftalmologica Los Andes

  PRINCIPAL INVESTIGATOR

• Juan Stoppel Ortiz, MD

  Fundacion Oftalmologica Los Andes

  PRINCIPAL INVESTIGATOR

• Felipe Valenzuela Santana, MD

  Fundación Oftalmológica Los Andes

  STUDY CHAIR

• Cristobal Loezar Hernandez, MD

  Fundacion Oftalmologica Los Andes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe Valenzuela Santana, MD

CONTACT

23704633; felipevalenz@gmail.com

Cristobal Loézar Hernández, MD

CONTACT

23704600; cristobal.loezar@uv.cl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be enrolled and randomly assigned by a computer generated randomization list in a 1:1:1 ratio to the intervention groups (2) or the control group. After cataract surgery, all groups will be given a topical steroid-antibiotic (tobramycin 0.3% and dexamethasone acetate 0.1%) commercially available and commonly used by ophthalmologists worldwide postoperatively, in a 3-week tapered regimen (every 2 hours the first day, then every 4 hours for 6 days, then 3 times a day for 1 week and twice a day for 1 week). The 2 study groups will be also prescribed lubricant eye drops from the postoperative day 7 containing sodium hyaluronate 0.1% (in 2 different commercially available formulations) to instill 4 times daily for the following 3 months. Study group patients will be instructed to instill the lubricant eyedrops at least 10 minutes after the tobramycin-dexamethasone eyedrops. At postoperative visits, patients will be asked about compliance with the assigned treatment.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: July 15, 2023
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share