Tear Osmolarity Clinical Utility in Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.

It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dry Eye Treatment With Artificial Tears

NCT02420834

Dry Eye

COMPLETED NA

The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease

NCT02260960

Dry Eye Disease

COMPLETED PHASE2/PHASE3

The Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease

NCT06748768

Dry Eye

ACTIVE_NOT_RECRUITING

Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects

NCT01970917

Dry Eye Syndrome Healthy

COMPLETED PHASE4

Mechanisms of Light-based Therapies for Dry Eye Disease

NCT06004895

Dry Eye Syndromes Meibomian Gland Dysfunction

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Application as required to improve comfort

Hypromellose - standard treatment

Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days

Group Type ACTIVE_COMPARATOR

Tear supplement

Intervention Type OTHER

Application as required to improve comfort

Combination treatment

Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;

Group Type ACTIVE_COMPARATOR

Tear supplement 2

Intervention Type OTHER

Application as required to improve comfort

Omega 3 nutrition supplement

Intervention Type DIETARY_SUPPLEMENT

Taken each day

Eye bag

Intervention Type DEVICE

Applied following microwave heating to closed eyelids for 5 minutes each day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tear supplement

Application as required to improve comfort

Intervention Type OTHER

Tear supplement 2

Application as required to improve comfort

Intervention Type OTHER

Omega 3 nutrition supplement

Taken each day

Intervention Type DIETARY_SUPPLEMENT

Eye bag

Applied following microwave heating to closed eyelids for 5 minutes each day

Intervention Type DEVICE

Saline

Application as required to improve comfort

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hypermellose 0.3% eye drop Hylo-Forte 0.2% Sodium Hyaluronate eye drop Scope Ophthalmics Omega Eye TranquilEyes Moist Heat Lid Minim sodium chloride 0.9% unpreserved

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Dry Eye Symptoms SPEED \>8

Exclusion Criteria

* Unable to participate in 90 days therapy
* Allergic to therapy
* On medication known to affect ocular surface / tear film
* Had ocular trauma, infection or surgery
* Diagnosed with a medical condition known to affect ocular surface / tear film

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No