RECRUITING

Performance of Systane PRO Versus Refresh Optive Mega-3

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Single site, prospective, double-masked, randomized-controlled, cross-over study of the subjective and objective performance of 2 different eyedrops. Subjects will be assessed at a screening visit, and 3 follow-up visits. Clinical evaluations will include patient questionnaires.

Official Title

Subjective and Objective Performance of Systane PRO Versus Refresh Optive Mega-3 in Dry Eye Patients

Quick Facts

Study Start:2025-06-01

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06975891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects who currently have moderate symptoms of dry eye as defined by a baseline OSDI score of 23-32 inclusive. * Subjects between ages of 18-65 inclusive. * Subjects who do not currently wear contact lenses. * Subjects willing to fill out a daily diary during the duration of the study. * Subjects willing to comply with the prescribed regimen and schedule of eye drops. * Subjects willing to attend all study visits.	* Have an ophthalmologic diagnosis of: allergy, viral or bacterial conjunctivitis, anterior blepharitis, parasitic infestations in any ocular structure or its adnexa, unresolved ocular trauma, ocular surface scarring diseases, corneal or conjunctival ulcers, filamentous keratitis, neurotrophic keratitis, bulous keratopathy, neoplastic diseases on the ocular surface or adnexa, diseases with fibrovascular proliferations on the conjunctival and/or corneal surface, retinal and/or posterior diseases that require treatment or threaten the visual prognosis, or glaucoma. * Eyelid disorders that cause eyelid malposition, limit adequate eyelid closure or opening or cause epiphora. * History of herpetic keratitis or ocular surgery. * Have dry eye management that requires the implementation of any treatments (except artificial tears) of stage 2 of the recommendations in the treatment and management by stages for the dry eye disease of the TFOS DEWS I\\| (Tear Film and Ocular Surface Society Dry Eye Workshop I). * Have a history of drug addiction or drug dependence currently or within the last two years before signing the ICF. * Have another medical condition, acute or chronic, that in the opinion of the investigator could increase the risk associated with participation in the study or the administration of the investigational product, or that could interfere with the interpretation of the results of the study. * Pregnant or lactating. * Current use of contact lenses. * Have participated in another clinical research study ≤30 days before screening visit. * Any use of eye drops, whether OTC or Rx, in last 14 days. * Subjects who have previously used either investigational product in the past. * Have known hypersensitivity to the components of the investigational product.

Inclusion Criteria

Exclusion Criteria

* Subjects who currently have moderate symptoms of dry eye as defined by a baseline OSDI score of 23-32 inclusive.
* Subjects between ages of 18-65 inclusive.
* Subjects who do not currently wear contact lenses.
* Subjects willing to fill out a daily diary during the duration of the study.
* Subjects willing to comply with the prescribed regimen and schedule of eye drops.
* Subjects willing to attend all study visits.

* Have an ophthalmologic diagnosis of: allergy, viral or bacterial conjunctivitis, anterior blepharitis, parasitic infestations in any ocular structure or its adnexa, unresolved ocular trauma, ocular surface scarring diseases, corneal or conjunctival ulcers, filamentous keratitis, neurotrophic keratitis, bulous keratopathy, neoplastic diseases on the ocular surface or adnexa, diseases with fibrovascular proliferations on the conjunctival and/or corneal surface, retinal and/or posterior diseases that require treatment or threaten the visual prognosis, or glaucoma.
* Eyelid disorders that cause eyelid malposition, limit adequate eyelid closure or opening or cause epiphora.
* History of herpetic keratitis or ocular surgery.
* Have dry eye management that requires the implementation of any treatments (except artificial tears) of stage 2 of the recommendations in the treatment and management by stages for the dry eye disease of the TFOS DEWS I\| (Tear Film and Ocular Surface Society Dry Eye Workshop I).
* Have a history of drug addiction or drug dependence currently or within the last two years before signing the ICF.
* Have another medical condition, acute or chronic, that in the opinion of the investigator could increase the risk associated with participation in the study or the administration of the investigational product, or that could interfere with the interpretation of the results of the study.
* Pregnant or lactating.
* Current use of contact lenses.
* Have participated in another clinical research study ≤30 days before screening visit.
* Any use of eye drops, whether OTC or Rx, in last 14 days.
* Subjects who have previously used either investigational product in the past.
* Have known hypersensitivity to the components of the investigational product.

Contacts and Locations

Study Contact

Leslie Shan, OD

CONTACT

858-530-2800

lshanod@gmail.com

Principal Investigator

Jay Mashouf, OD

PRINCIPAL_INVESTIGATOR

Scripps Optometric Group

Study Locations (Sites)

Scripps Poway Eyecare & Optometry

San Diego, California, 92131

United States

Collaborators and Investigators

Sponsor: Scripps Poway Eyecare and Optometry

Jay Mashouf, OD, PRINCIPAL_INVESTIGATOR, Scripps Optometric Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

Dry Eye