Ocular Lubricant for Dry Eye Syndrome

No longer recruiting at 9 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Systemic dry eye medications

Disqualifiers: Pregnancy, Ocular abnormalities, Uncontrolled diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, FID123300 ocular lubricant, to evaluate its effectiveness and safety for individuals with mild to moderate dry eye disease. Symptoms of dry eye disease often include itching, burning, or a gritty sensation in the eyes. Participants will apply the eye drops four times daily for 30 days. This trial suits those experiencing dry eye symptoms and willing to discontinue their current artificial tears during the study. As an unphased trial, it provides an opportunity to advance the understanding of new treatments for dry eye disease.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using all artificial tear supplements and only use the study product. It doesn't specify about other medications, but you can't use systemic medications known to cause dry eye.

What prior data suggests that this ocular lubricant is safe for dry eye syndrome?

Research has shown that the FID123300 eye lubricant has been tested for safety and tolerability in individuals with mild to moderate dry eye disease. In these studies, researchers assessed whether participants could use the lubricant without major side effects.

Participants generally applied the drops several times a day, and results indicated that the lubricant was well-tolerated. No serious side effects were reported. Some individuals might experience mild irritation or discomfort, which is common when trying new eye drops.

These findings suggest that FID123300 is safe for use, especially since it has undergone prior testing. Always discuss any concerns or side effects with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Dry Eye Syndrome, like artificial tears and prescription eye drops, focus on providing temporary relief by lubricating the eyes. However, FID123300 is unique because it promises prolonged comfort with fewer applications throughout the day. Unlike typical treatments, which often require frequent use, FID123300 may achieve similar or better results with just four applications daily, enhancing convenience for users. Researchers are excited about the potential of FID123300 to offer a more efficient and lasting solution for those suffering from dry eyes.

What evidence suggests that this ocular lubricant is effective for dry eye disease?

Research has shown that eye drops like FID123300, which participants in this trial will receive, can help manage dry eye symptoms. These drops add moisture to the eyes, improving their condition. One study found that this new eye drop formula effectively reduced dry eye symptoms. As a result, people using FID123300 might experience less irritation and discomfort in their eyes. Overall, the results are promising for those seeking relief from dry eye disease. ^{2 3 4 6 7}

Who Is on the Research Team?

Sr. Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate dry eye disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit

I am willing to stop using my current eye drops and only use the study's eye drops starting from Visit 2/Day 1.

I have symptoms of dry eye.

Exclusion Criteria

I do not have eye problems that could affect treatment results.

Pregnant, breastfeeding, or planning to become pregnant during the study

I do not have any uncontrolled diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

7 days

1 visit (in-person)

Treatment

Participants receive one drop of FID123300 ocular lubricant in each eye on Day 1, followed by at least one drop in each eye 4 times a day on Days 2-30

30 days

1 visit (in-person), 1 remote compliance check

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FID123300 ocular lubricant

Trial Overview The trial is testing a new eye drop called FID123300 designed to lubricate the eyes. The goal is to see if it's effective and safe in providing relief for those suffering from symptoms of dry eye syndrome.

How Is the Trial Designed?

Group I: FID123300 Experimental Treatment 1 Intervention

One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

Carnidrop significantly improved fluorescein break-up time (FBUT) and Ocular Protection Index (OPI) in patients with dry eye syndrome compared to other lubricant eye drops, indicating better tear film stability and quality.

The effectiveness of Carnidrop may be attributed to its hypo-osmolarity and high content of osmolytes like L-carnitine, suggesting it could be a promising treatment option for restoring physiological tear film conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three lubricant eye drop solutions in dry eye patients. Evangelista, M., Koverech, A., Messano, M., et al.[2022]

In a study of 110 non-contact lens wearers, a novel ocular lubricant provided significantly higher comfort ratings compared to a commercially marketed lubricant, with 71% of users reporting improved comfort.

While the novel lubricant showed better subjective comfort, objective clinical measures like visual acuity and tear quality were similar between both groups, indicating that the new lubricant is effective in enhancing user experience without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of the efficacy of a novel ocular lubricant. Dumbleton, K., Woods, C., Fonn, D.[2015]

In a phase 3 study involving 599 adults with dry eye disease, NOV03 (perfluorohexyloctane) significantly improved eye dryness and corneal staining compared to saline, showing clinically meaningful benefits after 8 weeks of treatment.

The treatment was well tolerated, with most side effects being mild and no serious adverse events reported, indicating a favorable safety profile for NOV03 in managing dry eye disease associated with meibomian gland dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. Tauber, J., Berdy, GJ., Wirta, DL., et al.[2023]

In a study involving 28 participants with dry eye disease, both lipid-based (Systane Complete) and non-lipid-based (Systane Ultra) artificial tears improved symptoms and tear film stability after application.

However, the lipid-containing eye drop showed superior benefits in preserving tear film quality and reducing dry eye symptoms after exposure to adverse conditions, indicating it may be more effective for managing dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial. Muntz, A., Marasini, S., Wang, MTM., et al.[2021]

The new benzalkonium chloride-free Visine® lubricant eye drop formulation (GentlePur™) was found to be very comfortable for both healthy and dry eye subjects, with comfort scores improving over the 14-day study period.

The eye drops demonstrated safety with no significant adverse events reported, and they effectively reduced corneal staining in dry eye subjects, indicating potential benefits for ocular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and comfort evaluation of a new formulation of Visine(®) lubricant eye drops containing HydroBlend™ and GentlePur™. Torkildsen, G., Frisch, S., Bai, M., et al.[2020]

In a study involving 231 adults with lipid-deficient dry eye, Systane® Balance (SYSB) was found to be non-inferior to Refresh® Optive Advanced (RFO-Ad) in improving tear film breakup time (TFBUT) after 35 days of use, indicating similar efficacy between the two treatments.

Both eye drop treatments significantly improved TFBUT and reduced ocular discomfort, and were well tolerated by participants, suggesting they are safe options for managing lipid-deficient dry eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease. Jerkins, G., Greiner, JV., Tong, L., et al.[2022]

In a clinical trial involving 39 participants with moderate dry eye disease, recombinant human lubricin significantly reduced symptoms such as foreign body sensation, burning, and blurred vision compared to 0.18% sodium hyaluronate eye drops.

Lubricin also improved objective measures of dry eye, including corneal staining and tear film breakup time, with no reported adverse events, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients with Moderate Dry Eye Disease. Lambiase, A., Sullivan, BD., Schmidt, TA., et al.[2018]

The use of an ophthalmic viscosurgical device (OVD) during cataract surgery significantly improved indicators of dry eye syndrome, such as tear break-up time and corneal staining, one week post-operation in a study of 24 patients.

Applying the OVD was associated with longer surgery times, but it provided protective benefits to the ocular surface, suggesting it is a valuable addition to cataract surgery procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Protective Effect of an Ophthalmic Viscosurgical Device on the Ocular Surface in Dry Eye Patients during Cataract Surgery. Yoon, DY., Kim, JH., Jeon, HS., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-dry-eye-syndromes-7-2024-ad496

Ocular Lubricant for Dry Eye Syndrome · Info for Participants This study found that the new lubricant was effective in managing symptoms. Additionally, another study compared a different type of eye drop with a common ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19686307/

Efficacy of different dry eye treatments with artificial tears or ... Treatment of dry eye with artificial tears or ocular lubricants can be expected to improve the condition of the exposed ocular surface.

3. ctv.veeva.com ctv.veeva.com/study/study-of-safety-and-performance-of-a-novel-ocular-lubricant-in-subjects-with-dry-eye-disease

Study of Safety and Performance of a Novel Ocular Lubricant ... The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT01797822?keyword=%22Keratoconjunctivitis%20Sicca%22

Effects of Dry Eye Treatments on the Ocular Surface This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased ...

5. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=21317&isClinicalTrial=True

ANZCTR - Registration For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. Other: FID122505/ ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05888519

Study Details | NCT05888519 | Evaluation of Safety and ... The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06571656

Evaluation of the Safety and Tolerability of Ocular Lubricants The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.