Dry Eye DiseasePhase 2NCT07264517
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
A Phase 2 study testing GRF312 5% in people with Dry Eye Disease, run by Instituto Grifols, S.A. at 10 sites in United States.
Trial summary
This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- GRF312 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Nov 2025to 20 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Has a known hypersensitivity or contraindication to the study drug(s) or their components.
- In the opinion of the Investigator, be unwilling or unable to comply with the study protocol or unable to successfully self-administer eye drops.
- Use of any IP or device within 30 days prior to start of the Screening or during the study period.
- Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, eyelid margin disorders (e.g., significant blepharitis including staphylococcal, demodex or seborrheic; severe meibomian gland disease, excessive lid laxity, floppy eyelid syndrome, ectropion or entropion), advanced conjuctivochalasis, Salzmann's nodular degeneration, iritis, uveitis, and/or active ocular infection.
- Participants with DED secondary to scarring (such as that seen with irradiation, alkali burns, Steven-Johnson syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (as with Vitamin A deficiency) are not eligible for the study. Participants with incidental scars secondary to refractive surgery (i.e., LASIK surgery) that, in the opinion of the Investigator, will not interfere with study compliance and/or outcome measures are not excluded from the study.
- Known history of alcohol and/or drug abuse within the past 12 months, that in the opinion of the Investigator, may interfere with study compliance, outcome measures including safety parameters, and/or general medical condition of the participant.
Show all 18Show fewer
- History of active herpes simplex or zoster keratitis in either eye.
- History of neurotrophic keratitis or suspected history of neurotrophic keratitis in the clinical judgement of the Investigator (e.g., abnormal Cochet-Bonnet test).
- Intraocular pressure (IOP) > 22 mmHg at the Screening Visit.
- Use of below listed medications and/or procedures within the appropriate pre-study period and throughout the study:
- Prohibited during the Screening Visit and throughout the study: i. Artificial tear substitutes ii. Current use of eye drops for glaucoma b. Prohibited 7 days prior to the Screening Visit and throughout the study: i. Contact Lenses c. Prohibited 14 days prior to the Screening Visit and throughout the study: i. Topical ocular or systemic antibiotics ii. Serum tears iii. Topical ocular non-steroidal anti-inflammatory drugs (NSAIDS) iv. Topical ocular or oral antihistamines or mast cell stabilizers v. Topical ocular or nasal vasoconstrictors. Phenylephrine to dilate is allowed.
- Prohibited 30 days prior to the Screening Visit and throughout the study: i. Ocular, inhaled or intranasal or dermatologic corticosteroids. This includes corticosteroids creams used anywhere on the body.
- Lifitegrast iii. Perfluorohexyloctane ophthalmic solution iv. Oxymetazoline ophthalmic solution v. 0.25% lotilaner ophthalmic solution vi. Intranasal tear neurostimulation vii. Punctal cautery and short-term dissolvable punctal plugs. Permanent punctal plugs should not be in place at least 30 days prior to the Screening Visit.
- Any topical ophthalmic medications (or makeup) used for eyelash growth e. Prohibited 6 weeks prior to the Screening Visit and throughout the study: i. Topical ocular cyclosporine f. Prohibited 3 months prior to the Screening Visit and throughout the study: i. Yttrium aluminum garnet-laser posterior capsulotomy or any laser ocular surgery ii. Punctal plugs that are long-term dissolvable g. Prohibited 6 months prior to the Screening Visit and throughout the study: i. Mechanical treatments for Meibomian Gland Dysfunction (MGD) including but not limited to thermal pulsation (Lipiflow or iLux), debridement of lid margin (BlephEx), thermal application (MeiBoFlo, Tear Care), or meibomian gland probing ii. Eyelid surgery iii. Ocular placement of amniotic membrane in either eye h. Prohibited 12 months prior to the Screening Visit and throughout the study: i. Any incisional intraocular surgical procedure ii. Have had incisional ocular surface surgery, including but not limited to LASIK or similar type of corneal refractive surgery and pterygium removal i. Prior history i. Use of isotretinoin ii. Corneal transplant or partial corneal transplant
- Any significant chronic illness that, in the opinion of the Investigator, could interfere with the study parameters, including, but not limited to, severe cardiopulmonary disease, poorly controlled hypertension, and/or poorly controlled diabetes.
- Has known previous or current infection of Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV).
- A participant must NOT meet the following exclusion criterion at the Randomization (Day 1) to be eligible for participation in this study:
- 14. Non-compliance (< 80% or > 120%) with vehicle regimen in the Run-in Period.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
GC2302 Study Site 104
Asheville, North Carolina, 28803
GC2302 Study Site 106
Carmel, Indiana, 46290
GC2302 Study Site 107
Cranberry Township, Pennsylvania, 160166
GC2302 Study Site 101
Garner, North Carolina, 27529
GC2302 Study Site 110
Glendale, California, 91204
GC2302 Study Site 109
Grove, California, 92843
GC2302 Study Site 102
Memphis, Tennessee, 38119
GC2302 Study Site 105
Morrow, Georgia, 30260
GC2302 Study Site 103
Newport Beach, California, 92663
GC2302 Study Site 111
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Double-masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease
This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.
- Conditions
- Dry Eye Disease
- Being tested
- GRF312 5%, Placebo Comparator
- Keywords
- Phase 2, artificial tear product, primary or secondary Sjogren's syndrome, autoimmune diseases, moderate to severe dry eye disease
- Medical subject headings
- Dry Eye Syndromes, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRF312 5%Drug
Immune Globulin (Human), (GRF312 5% Ophthalmic Solution
Placebo ComparatorOther
Vehicle.
| Study group | Role | What they receive |
|---|---|---|
| Group A: GRF312 5% administered b.i.d. (morning/evening) | Experimental | Not described Receives: Drug: GRF312 5% |
| Group B: Vehicle administered b.i.d. (morning/evening) | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation.
Measured: Up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start3 Nov 2025
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264517
- Sponsor's protocol ID
- GC2302
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07264517
- Acronym / sponsor ID
- GC2302
- Conditions
- Dry Eye Disease
- Keywords
- Phase 2, artificial tear product, primary or secondary Sjogren's syndrome, autoimmune diseases, moderate to severe dry eye disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: GRF312 5% administered b.i.d. (morning/evening) | Experimental | Drug: GRF312 5% |
| Group B: Vehicle administered b.i.d. (morning/evening) | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Has a known hypersensitivity or contraindication to the study drug(s) or their components.
- In the opinion of the Investigator, be unwilling or unable to comply with the study protocol or unable to successfully self-administer eye drops.
- Use of any IP or device within 30 days prior to start of the Screening or during the study period.
- Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, eyelid margin disorders (e.g., significant blepharitis including staphylococcal, demodex or seborrheic; severe meibomian gland disease, excessive lid laxity, floppy eyelid syndrome, ectropion or entropion), advanced conjuctivochalasis, Salzmann's nodular degeneration, iritis, uveitis, and/or active ocular infection.
- Participants with DED secondary to scarring (such as that seen with irradiation, alkali burns, Steven-Johnson syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (as with Vitamin A deficiency) are not eligible for the study. Participants with incidental scars secondary to refractive surgery (i.e., LASIK surgery) that, in the opinion of the Investigator, will not interfere with study compliance and/or outcome measures are not excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRF312 5%Immune Globulin (Human), (GRF312 5% Ophthalmic Solution | Drug | Group A: GRF312 5% administered b.i.d. (morning/evening) |
| Placebo ComparatorVehicle. | Other | Group B: Vehicle administered b.i.d. (morning/evening) |
Primary outcome
Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation.
Time frame: Up to Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRF312 5% in people with Dry Eye Disease, run by Instituto Grifols, S.A. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation. (time frame: Up to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.