Ocular Lubricants for Dry Eye Syndrome

Not yet recruiting at 4 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must be taking: Artificial tears

Disqualifiers: Active ocular disease, Ocular infection, Contact lenses, others

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

Compensation: Varies

Number of Visits: 1

Duration: 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and comfort of two new eye drop formulations, FID123437 and FID123440, which may help with moderate dry eye disease. Participants will try each formulation on separate days to assess comfort and identify any side effects. The trial targets individuals who regularly experience dry eyes and already use artificial tears to manage symptoms. Participants should not have recent eye infections or wear contact lenses. As an unphased trial, this study allows participants to contribute to early research that could lead to improved treatments for dry eye disease.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that artificial tears, like those under study, are usually gentle on the eyes. Studies have found that both FID123437 and FID123440, the two types being tested, are safe to use. No reports of serious side effects have emerged. Most people experience only mild irritation, if any, which is common with eye drops. The researchers aim to ensure these new formulas are also comfortable and safe for people with moderate dry eye disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the new ocular lubricants FID123437 and FID123440 for treating Dry Eye Syndrome because they offer a potentially faster onset of relief compared to standard artificial tears. Unlike many current treatments that require regular application over weeks to see improvement, FID123437 and FID123440 are designed to show effectiveness within just a day. This could mean quicker comfort for patients suffering from dry eyes, providing a significant advantage over existing options.

What evidence suggests that this trial's treatments could be effective for dry eye syndrome?

Research has shown that both FID123437 and FID123440, tested in this trial, are promising treatments for dry eye syndrome. Participants will receive either FID123437 followed by FID123440 or vice versa. Studies have found that treatments with ingredients similar to those in FID123437 and FID123440 can effectively reduce eye irritation and help maintain moisture. For instance, these treatments have managed keratoconjunctivitis sicca (a form of dry eye) by preventing further damage and providing relief. Additionally, similar products have been well-tolerated by patients with moderate dry eye, indicating they are safe and effective options. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trial Lead, Dry Eye

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with moderate dry eye disease. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

Other protocol-defined inclusion criteria may apply

I am willing and able to sign a consent form.

I can attend all required study visits.

Exclusion Criteria

Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month

Other protocol-defined exclusion criteria may apply

I have an active eye disease or infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive one drop of each investigational product in a cross-over design

21 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 to 13 days

Exit visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FID123437 test formulation
• FID123440 test formulation

Trial Overview The safety and tolerability of two new artificial tear formulations, identified as FID123437 and FID123440, are being evaluated in this study.

How Is the Trial Designed?

Group I: Sequence 2: FID123437, then FID123440 Experimental Treatment 2 Interventions

One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Group II: Sequence 1: FID123440, then FID123437 Experimental Treatment 2 Interventions

One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01797822

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2709003/

Treatment of patients with keratoconjunctivitis sicca with ... In this observational study, the use of Optive was effective and well tolerated in patients with dry eye. Acknowledgments. This study was supported by ...

3. emedicine.medscape.com emedicine.medscape.com/article/1210417-treatment

Dry Eye Disease (Keratoconjunctivitis Sicca) Treatment & ... Early detection and aggressive treatment of dry eye disease (DED), or keratoconjunctivitis sicca (KCS), may help prevent corneal ulcers and scarring.

4. walshmedicalmedia.com walshmedicalmedia.com/open-access/development-of-opthalmic-formulation-for-dry-eye-syndrome-2167-1052-3-166.pdf

development-of-opthalmic-formulation-for-dry-eye- ... The formulation was evaluated for viscosity and eye irritation test. ... serum, have been effective for management of dry eye. In addition ...

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07238699?aggFilters=status%3A%2CfunderType%3Aindustry

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

7. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-an-evaluation-of-the-safety-and-tolerability-of-ocular-lubricants/555773767

Clinical Trial: An Evaluation of the Safety and Tolerability ... Brief Summary: The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7913303/

Formulation Considerations for the Management of Dry ... A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01294384

Safety and Efficacy Study of New Eye Drop Formulations ... This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye ...

10. bcbsnm.com bcbsnm.com/docs/provider/nm/standards/cpcp/cpcplab043-8-8-2025.pdf

CPCPLAB043 - Evaluation of Dry Eyes osmolarity test in patients presenting with dry eye disease like symptoms: A prospective analysis. Cont Lens Anterior Eye. Apr 2019;42(2): ...