NCT05660681

Brief Summary

The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

November 23, 2022

Last Update Submit

September 4, 2023

Conditions

Dry Eye Disease

Keywords

Corneal EpitheliopathyTear Film Stability

Outcome Measures

Primary Outcomes (1)

  • Tear Film Break-up Time

    State-of-the-art methodology to assess tear stability.

    15 minutes after eye drop instillation

Study Arms (2)

glycerin 0.7%/PEG 400 0.3%

EXPERIMENTAL

20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days.

Drug: glycerin 0.7%/PEG 400 0.3%

polyethylene glycol 400 0.4%/propylene glycol 0.3%

ACTIVE COMPARATOR

10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days.

Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%

Interventions

glycerin 0.7%/PEG 400 0.3%DRUG

Eye drop with active agents from the OTC Monograph.

Also known as: CWT-f-002
glycerin 0.7%/PEG 400 0.3%
polyethylene glycol 400 0.4%/propylene glycol 0.3%DRUG

Eye drop with active agents from the OTC Monograph.

Also known as: Systane (R)
polyethylene glycol 400 0.4%/propylene glycol 0.3%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years of age
  • Have a reported history of dry eye for at least 6 months
  • Have a Tear Film Breakup Time (TFBUT) measurement of \>1 and \<7 seconds at Visit 1

You may not qualify if:

  • Known contraindications or sensitivities to the use of the study treatment or any of its components
  • Have a clinically significant slit lamp finding at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
  • Have a condition (ocular or systemic) that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Research Eye Institute

Andover, Massachusetts, 01810, United States

Location

Related Publications (3)

  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

    PMID: 28736335BACKGROUND

  • Farrand KF, Fridman M, Stillman IO, Schaumberg DA. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. 2017 Oct;182:90-98. doi: 10.1016/j.ajo.2017.06.033. Epub 2017 Jul 10.

    PMID: 28705660BACKGROUND

  • Gensheimer WG, Kleinman DM, Gonzalez MO, Sobti D, Cooper ER, Smits G, Loxley A, Mitchnick M, Aquavella JV. Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops. J Ocul Pharmacol Ther. 2012 Oct;28(5):473-8. doi: 10.1089/jop.2011.0053. Epub 2012 May 3.

    PMID: 22554205BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Glycerolpolyethylene glycol 400

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Paul Gomes, MS

    Andover Research Eye Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-masked, single-center, interventional trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 21, 2022

Study Start

December 12, 2022

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)