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Home › Conditions › Dry Eye Disease

Dry Eye Disease

10 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Dry Eye Disease

206 trials tracked for Dry Eye Disease: 66 in phase 3 or 4 and 20 with published results. The most-cited published study has 218 citations.

206Trials tracked
66Phase 3 & 4
0Recruiting
20With published results
Phase distribution
Phase 4 21 Phase 3 45 Phase 2 58 Phase 1 4 Other / NA 78
  1. Phase 3 Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) Completed · 218 cited
  2. Phase 3 A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) Completed · 210 cited
  3. Phase 3 A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye Completed · 194 cited
  4. Phase 3 Safety Study of Lifitegrast to Treat Dry Eye Completed · 100 cited
  5. Phase 3 Dry Eye Assessment and Management Study Completed · 80 cited
  6. Phase 3 ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Completed · 70 cited
Show 44 more trials
  1. Phase 3 Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study) Completed · 65 cited
  2. Phase 3 CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Completed · 56 cited
  3. Phase 3 Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye Completed · 48 cited
  4. Phase 3 Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye Completed · 25 cited
  5. Phase 4 Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra) Completed · 20 cited
  6. Phase 3 Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis? Completed · 16 cited
  7. Phase 3 A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye Completed · 13 cited
  8. Phase 3 Study Evaluating the Safety and Efficacy of AR-15512 Completed · 12 cited
  9. Phase 3 Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3) Completed · 12 cited
  10. Phase 4 Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease Completed · 8 cited
  11. Phase 4 Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. Completed · 8 cited
  12. Phase 4 A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease Completed · 8 cited
  13. Phase 4 Nasal Spray Study in Sjogren's Dry Eye Disease Completed · 4 cited
  14. Phase 3 A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease Completed
  15. Phase 4 Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV) Completed
  16. Phase 4 Effects of Dry Eye Treatments on the Ocular Surface Completed
  17. Phase 4 Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears Completed
  18. Phase 4 Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort Completed
  19. Phase 4 Direct Application of Systane Complete to Contact Lenses Completed
  20. Phase 4 The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED Completed
  21. Phase 4 Digital Device Users Who Are Treated With Systane Hydration PF Completed
  22. Phase 4 Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax Completed
  23. Phase 4 Effect of Cequa™ in Subjects With Dry Eye Disease Completed
  24. Phase 4 Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Completed
  25. Phase 4 Artificial Tears, Tear Lipids and Tear Film Dynamics Completed
  26. Phase 4 Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance Completed
  27. Phase 4 The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers Completed
  28. Phase 4 Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya Completed
  29. Phase 4 Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye Completed
  30. Phase 4 Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery Completed
  31. Phase 3 Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome Completed
  32. Phase 3 Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca Completed
  33. Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease Completed
  34. Phase 3 A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease Completed
  35. Phase 3 Confirmatory Study of OPC-12759 Ophthalmic Solution Completed
  36. Phase 3 Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment Completed
  37. Phase 3 Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome Completed
  38. Phase 3 Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 Completed
  39. Phase 3 Study of SkQ1 as Treatment for Dry-eye Syndrome Completed
  40. Phase 3 Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome Completed
  41. Phase 3 A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes Completed
  42. Phase 3 Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED) Completed
  43. Phase 3 Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Completed
  44. Phase 3 Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) Completed

Showing the 50 most-cited and recently-updated of 206 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Dry Eye Disease: what the trials found

New clinical evidence demonstrates that 0.003% AR-15512 ophthalmic solution significantly improves Tear Meniscus Height (TMH) at Minute 3 in both Stage 1 and Stage 2 patients (p<0.0001) 4. This intervention was associated with a 0% to 3.6% rate of treatment-emergent adverse events 3, though it did not show a statistically significant change in Goblet Cell Density at Day 90 (p=0.1765) 2.

T2769 was shown to be non-inferior to Hylo-Forte® regarding Total Ocular Surface Staining (Oxford Score) 14. Other established interventions include Sodium hyaluronate 0.1% with chondroitin sulfate 0.18% 1, Rohto (r) Hydra 15, Miebo 16, Corticotropin 80Unit/Ml Repository Injection 17, Varenicline Nasal Spray, which showed a mean reduction in eye dryness score on the Visual Analogue Scale (VAS) of -14.51 18, and Nasal Guide 19.

Xiidra demonstrated statistically significant improvements in both contact lens-related discomfort and contact lens-related dryness at 12 weeks compared to baseline (p<0.01) 20. Several other formulations, including Systane Complete Multi-Dose PF 21 and Systane Complete PF 22, are established for use.

Recent results — preliminary, needs further review

  • INV-102 showed a reduction in Eye Dryness Score (VAS) of -15.50 to -21.20 and an improvement in the Eye Dryness Composite Score by approximately 10 to 13 points at Day 15 7.
  • FID123300 ocular lubricant significantly improved the Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) score at Day 30 (p<0.0001) 12.
  • IVW-1001 Ophthalmic Eyelid Wipe showed reductions in Corneal Fluorescein Staining Scores and improvements in SANDE scores for both frequency and severity of symptoms 10.
  • Systane iLux treatment resulted in mixed/conflicting results regarding Lipid Layer Thickness (LLT) at 4 weeks post-operative follow-up, with reported changes of -1.9 and 19.5 11.
  • rhNGF 5 μg/mL did not reach statistical significance for improvements in SANDE Global Scores (p=0.076), Schirmer-I Test results (p=0.534), or Schirmer-I scores (p=0.260) 9.

For the clinician treating this condition

  • 0.003% AR-15512 is effective for increasing Tear Meniscus Height (TMH) but did not show significant impact on Goblet Cell Density.
  • Xiidra provides statistically significant improvements in symptoms specifically related to contact lens wear.
  • T2769 demonstrated non-inferiority to Hylo-Forte® regarding total ocular surface staining.
  • FID123300 and INV-102 showed significant improvements in patient-reported dryness scores and impact on daily life.

AI synthesis of 18 cited trials, updated Jun 21, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Hydrogels overcome physiological barriers to improve drug delivery and tissue repair in anterior segment diseases
Ophthalmology Sys. Review
Hydrogels overcome physiological barriers to improve drug delivery and tissue repair in anterior segment diseases Hydrogels Improve Drug Delivery for Various Eye Conditions
This systematic review evaluates hydrogel platforms including adhesive drops, thermosensitive gels, and drug-eluting lenses compared to conv…
New hydrogel technologies may overcome the limitations of standard eye drops to provide longer-lasting treatment for conditions like glaucom…
Frontiers Jul 8, 2026
Acoltremon 0.003% twice daily increased tear production in adults with Dry Eye Disease
Drug Pipeline RCT
Acoltremon 0.003% twice daily increased tear production in adults with Dry Eye Disease New dry eye treatment boosts tear production in adults over 30
In two randomized, multicenter, double-masked phase 3 trials in adults with Dry Eye Disease, acoltremon 0.003% twice daily significantly inc…
A new dry eye treatment boosted tear production and reduced eye discomfort in adults over 30, showing clear benefits over a placebo in two l…
May 1, 2026
Systematic review and meta-analysis of stem cell therapy for dry eye in Sjögren's syndrome
Allergy & Immunology Meta-analysis
Systematic review and meta-analysis of stem cell therapy for dry eye in Sjögren's syndrome Stem Cell Therapy Eases Dry Eye in Sjögren’s Syndrome Patients
This systematic review and meta-analysis evaluated stem cell therapy for patients with dry eye syndrome caused by Sjögren's syndrome.
New analysis shows stem cell therapy eases dry eye pain and improves tear flow for people with Sjögren’s syndrome.
Frontiers Apr 29, 2026
Manuka eye drops improve dry eye symptoms after cataract surgery compared to sodium hyaluronate
Ophthalmology Cohort
Manuka eye drops improve dry eye symptoms after cataract surgery compared to sodium hyaluronate Manuka drops may reduce dry eye symptoms after cataract surgery
This prospective controlled study in 53 patients undergoing cataract surgery found that Manuka eye drops (Leptospermum spp) significantly re…
A small study suggests Manuka eye drops might lower dry eye scores better than standard drops for one month after cataract surgery.
Frontiers Apr 28, 2026
Systematic review of 319 RCTs maps acupuncture and moxibustion for dry eye disease
Rheumatology RCT
Systematic review of 319 RCTs maps acupuncture and moxibustion for dry eye disease Acupuncture Helps Dry Eyes, But Data Needs Work
This evidence map synthesizes data from 319 randomized controlled trials evaluating acupuncture and moxibustion for patients with dry eye di…
Imagine waking up with gritty, burning eyes that won't stop watering.
Frontiers Apr 21, 2026
Review links blepharitis microbiota dysbiosis to ocular surface disease mechanisms
Ophthalmology Sys. Review
Review links blepharitis microbiota dysbiosis to ocular surface disease mechanisms Review links eye surface bacteria changes to blepharitis and dry eye conditions
This narrative review examines the relationship between blepharitis, microbiota dysbiosis, and ocular surface conditions including dry eye s…
Eye surface bacteria imbalances and Demodex mites may actively drive blepharitis and dry eye instead of just being bystanders.
Frontiers Apr 15, 2026
Jyothi Trataka yoga practice improves dry eye symptoms in adults with mild-to-moderate condition
Nephrology RCT
Jyothi Trataka yoga practice improves dry eye symptoms in adults with mild-to-moderate condition A 25-Minute Yoga Practice That Eases Dry, Painful Eyes
A 12-week randomized controlled trial of 49 adults with mild-to-moderate dry eye found that Jyothi Trataka practice improved OSDI scores sig…
A low-cost, screen-free yoga technique may offer real relief for people with dry eyes — no drops required.
Frontiers Apr 14, 2026
Review explores immunopathology of dry eye disease and emerging drug delivery systems
Rheumatology Sys. Review
Review explores immunopathology of dry eye disease and emerging drug delivery systems Why do dry eye treatments often fail? A new review points to inflammation
A systematic review examines immunopathological mechanisms in dry eye disease and recent advances in ophthalmic drug delivery systems.
Why do dry eye drops often fail? A new review shows inflammation, not just dryness, drives the disease, while new delivery systems aim to fi…
Frontiers Apr 1, 2026
Preclinical Review Suggests TCM Formulas Target Multiple Pathways in Dry Eye Disease Models
Drug Pipeline Sys. Review
Preclinical Review Suggests TCM Formulas Target Multiple Pathways in Dry Eye Disease Models Traditional Chinese Medicine studied for molecular effects on dry eye disease in lab models
A systematic review of preclinical evidence reports that Traditional Chinese Medicine metabolites, extracts, and formulas target multiple si…
Traditional Chinese Medicine formulas may target inflammation and cell death pathways in lab models, offering a theoretical basis for future…
Frontiers Apr 1, 2026
Perfluorohexyloctane Improves DED Symptoms in MGD Patients with Varied Baseline Severity
Drug Pipeline RCT
Perfluorohexyloctane Improves DED Symptoms in MGD Patients with Varied Baseline Severity Could new eye drops really ease dry eye symptoms for many patients?
Perfluorohexyloctane showed higher odds of improving EDS (OR: 2.25) and tCFS (OR: 2.21) in DED with MGD. Safety was consistent across severi…
New eye drops helped patients with severe dry eye feel better and improved their eye health more than saline, with few side effects.
Mar 28, 2026

Questions about Dry Eye Disease

What emerging drug delivery systems are being explored for Dry Eye Disease treatment?

Emerging drug delivery systems for dry eye disease include nanoparticles, hydrogels, liposomes, microspheres, and gene-based platforms, which aim to improve drug retention and bioavailability.

Full answer →
How do Traditional Chinese Medicine formulas target pathways in Dry Eye Disease models?

TCM formulas like Qiju Dihuang Pill target multiple pathways in dry eye disease models, including PI3K/AKT, MAPK, NF-κB, NLRP3, Nrf2, SIRT, AMPK, and VEGF, addressing inflammation, oxidative stress, and apoptosis.

Full answer →
Can Manuka eye drops improve dry eye symptoms after cataract surgery?

Yes, Manuka eye drops significantly improved dry eye symptoms and reduced inflammation after cataract surgery in a 2024 study, compared to standard sodium hyaluronate drops.

Full answer →